A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)

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ClinicalTrials.gov Identifier: NCT03197935

Recruitment Status : Completed

First Posted : June 23, 2017

Results First Posted : June 2, 2021

Last Update Posted : October 26, 2023

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Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Triple-negative Breast Cancer
Interventions	Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug: Placebo Drug: Nab-paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide Drug: Filgrastim Drug: Pegfilgrastim
Enrollment	333

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Period Title: Overall Study
Started	168	165
Completed	121	136
Not Completed	47	29
Reason Not Completed
Death due to any cause	26	15
Lost to Follow-up	3	5
Physician Decision	2	1
Withdrawal by Subject	16	8

Baseline Characteristics

Arm/Group Title		Placebo and Chemotherapy	Atezolizumab and Chemotherapy	Total
Arm/Group Description		Participants received placebo match...	Participants received atezolizumab ...	Total of all reporting groups
Arm/Group Description		Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.	Total of all reporting groups
Overall Number of Baseline Participants		168	165	333
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	168 participants	165 participants	333 participants
		50.3 (13.2)	50.1 (11.6)	50.2 (12.4)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	168 participants	165 participants	333 participants
	Female	168 100.0%	165 100.0%	333 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	168 participants	165 participants	333 participants
	Hispanic or Latino	47 28.0%	45 27.3%	92 27.6%
	Not Hispanic or Latino	114 67.9%	114 69.1%	228 68.5%
	Unknown or Not Reported	7 4.2%	6 3.6%	13 3.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	168 participants	165 participants	333 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	41 24.4%	47 28.5%	88 26.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	15 8.9%	9 5.5%	24 7.2%
	White	108 64.3%	102 61.8%	210 63.1%
	More than one race	0 0.0%	4 2.4%	4 1.2%
	Unknown or Not Reported	4 2.4%	3 1.8%	7 2.1%

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population
Description	Number of participants with Pathologic Complete Response (pCR) Using A...
Description	Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time Frame	After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Outcome Measure Data

Analysis Population Description

ITT population (full population) is defined as all randomized participants.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	168	165
Measure Type: Number Unit of Measure: Number of Participants
	69	95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0044
	Comments	(one-sided)
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Absolute difference in pCR rate
	Estimated Value	16.50
	Confidence Interval	(2-Sided) 95% 5.91 to 27.10
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System
Description	Number of participants with Pathologic Complete Response (pCR) Using A...
Description	Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.
Time Frame	After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Outcome Measure Data

Analysis Population Description

PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	75	77
Measure Type: Number Unit of Measure: Number of Participants
	37	53

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0206
	Comments	(one-sided)
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in pCR
	Estimated Value	19.50
	Confidence Interval	(2-Sided) 95% 4.17 to 34.83
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Event-Free Survival (EFS) in All Participants
Description	Event-free survival (EFS) defined as the time from randomization to th...
Description	Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

ITT population (full population) is defined as all randomized participants.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	168	165
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not estimable due low number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Other
	Comments	This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.47 to 1.21
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status
Description	Event-free survival (EFS) defined as the time from randomization to th...
Description	Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	75	77
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not estimable due low number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Other
	Comments	This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95% 0.26 to 1.18
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
Description	Disease-free survival (DFS) defined as the time from surgery to the fi...
Description	Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.
Time Frame	From surgery and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

ITT population (full population) is defined as all randomized participants. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	153	155
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not estimable due low number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Other
	Comments	This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.44 to 1.30
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery
Description	Disease-free survival (DFS) defined as the time from surgery to the fi...
Description	Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.
Time Frame	From surgery and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. Participants who do not undergo surgery at the end of neoadjuvant treatment are excluded from the analysis of DFS in the Subpopulation of Participants with PD-L1-Positive Tumor Status.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	67	73
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not estimable due low number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Other
	Comments	This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95% 0.23 to 1.43
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Overall Survival (OS) in All Participants
Description	Overall survival (OS) defined as the time from randomization to the da...
Description	Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

ITT population (full population) is defined as all randomized participants.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	168	165
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not estimable due low number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Other
	Comments	This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95% 0.30 to 1.04
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status
Description	Overall survival (OS) defined as the time from randomization to the da...
Description	Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

PD-L1-positive subpopulation is defined as participants in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.


Arm/Group Title	Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	75	77
Median (95% Confidence Interval) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

Not estimable due low number of events.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo and Chemotherapy, Atezolizumab and Chemotherapy
	Comments	Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).
	Type of Statistical Test	Other
	Comments	This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.

Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Stratified log-rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.26 to 1.91
	Estimation Comments	[Not Specified]

9.Secondary Outcome


Title	Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Description	Mean score in function (role, physical) and global health status(GHS)/...
Description	Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.


Arm/Group Title		Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:		Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:		Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed		167	161
Mean (95% Confidence Interval) Unit of Measure: Score on a 0-100 scale
GHS/QoL Baseline	Number Analyzed	167 participants	161 participants
GHS/QoL Baseline		76.45 (73.47 to 79.42)	79.24 (76.34 to 82.14)
GHS/QoL Cycle 2 Day 1	Number Analyzed	164 participants	157 participants
GHS/QoL Cycle 2 Day 1		71.90 (69.04 to 74.76)	71.55 (68.53 to 74.57)
GHS/QoL Cycle 3 Day 1	Number Analyzed	152 participants	143 participants
GHS/QoL Cycle 3 Day 1		65.30 (62.25 to 68.34)	62.65 (58.94 to 66.36)
GHS/QoL Cycle 4 Day 1	Number Analyzed	153 participants	149 participants
GHS/QoL Cycle 4 Day 1		62.36 (59.15 to 65.58)	59.84 (56.62 to 63.07)
GHS/QoL Cycle Cycle 5 Day 1	Number Analyzed	147 participants	139 participants
GHS/QoL Cycle Cycle 5 Day 1		60.37 (56.87 to 63.87)	53.60 (49.71 to 57.48)
GHS/QoL Cycle 6 Day 1	Number Analyzed	134 participants	132 participants
GHS/QoL Cycle 6 Day 1		74.25 (70.86 to 77.65)	70.14 (66.97 to 73.31)
GHS/QoL Cycle 7 Day 1	Number Analyzed	122 participants	128 participants
GHS/QoL Cycle 7 Day 1		76.50 (73.39 to 79.62)	73.57 (70.92 to 76.22)
GHS/QoL Cycle 8 Day 1	Number Analyzed	119 participants	122 participants
GHS/QoL Cycle 8 Day 1		77.17 (74.35 to 79.99)	72.06 (69.01 to 75.11)
GHS/QoL Cycle 9 Day 1	Number Analyzed	121 participants	121 participants
GHS/QoL Cycle 9 Day 1		75.62 (72.54 to 78.69)	72.18 (69.18 to 75.17)
GHS/QoL Cycle 10 Day 1	Number Analyzed	114 participants	122 participants
GHS/QoL Cycle 10 Day 1		75.22 (72.22 to 78.22)	70.56 (67.09 to 74.03)
GHS/QoL Cycle 11 Day 1	Number Analyzed	119 participants	122 participants
GHS/QoL Cycle 11 Day 1		75.98 (73.17 to 78.79)	71.93 (68.53 to 75.32)
GHS/QoL Cycle 12 Day 1	Number Analyzed	119 participants	122 participants
GHS/QoL Cycle 12 Day 1		75.84 (72.93 to 78.75)	72.40 (69.27 to 75.54)
GHS/QoL Cycle 13 Day 1	Number Analyzed	119 participants	121 participants
GHS/QoL Cycle 13 Day 1		74.72 (71.35 to 78.08)	72.87 (69.67 to 76.06)
GHS/QoL Cycle 14 Day 1	Number Analyzed	119 participants	116 participants
GHS/QoL Cycle 14 Day 1		74.79 (71.61 to 77.97)	71.19 (67.65 to 74.43)
GHS/QoL Cycle 15 Day 1	Number Analyzed	112 participants	116 participants
GHS/QoL Cycle 15 Day 1		75.00 (71.85 to 78.15)	74.07 (71.08 to 77.06)
GHS/QoL Cycle 16 Day 1	Number Analyzed	111 participants	114 participants
GHS/QoL Cycle 16 Day 1		77.70 (74.70 to 80.71)	74.93 (71.69 to 78.16)
GHS/QoL Study Drug Completion/ Early Discontinuation	Number Analyzed	130 participants	137 participants
GHS/QoL Study Drug Completion/ Early Discontinuation		75.38 (72.18 to 78.59)	72.51 (68.96 to 76.05)
GHS/QoL Survival Follow-Up Month 3	Number Analyzed	131 participants	142 participants
GHS/QoL Survival Follow-Up Month 3		76.97 (73.87 to 80.07)	72.65 (69.33 to 75.98)
GHS/QoL Survival Follow-Up Month 6	Number Analyzed	125 participants	136 participants
GHS/QoL Survival Follow-Up Month 6		74.93 (71.28 to 78.59)	75.61 (72.09 to 79.14)
GHS/QoL Survival Follow-Up Month 9	Number Analyzed	116 participants	132 participants
GHS/QoL Survival Follow-Up Month 9		75.00 (71.32 to 76.68)	75.19 (71.78 to 78.60)
GHS/QoL Survival Follow-Up Month 12	Number Analyzed	111 participants	126 participants
GHS/QoL Survival Follow-Up Month 12		75.15 (71.66 to 78.64)	74.87 (71.13 to 78.60)
GHS/QoL Survival Follow-Up Month 18	Number Analyzed	102 participants	112 participants
GHS/QoL Survival Follow-Up Month 18		76.39 (72.29 to 80.48)	75.60 (72.01 to 79.18)
GHS/QoL Survival Follow-Up Month 24	Number Analyzed	83 participants	108 participants
GHS/QoL Survival Follow-Up Month 24		78.31 (74.89 to 81.73)	74.46 (70.55 to 78.37)
GHS/QoL Survival Follow-Up Month 30	Number Analyzed	65 participants	72 participants
GHS/QoL Survival Follow-Up Month 30		78.33 (74.08 to 82.59)	73.50 (68.56 to 78.43)
GHS/QoL Survival Follow-Up Month 36	Number Analyzed	62 participants	69 participants
GHS/QoL Survival Follow-Up Month 36		78.63 (74.53 to 82.73)	76.93 (71.85 to 82.01)
GHS/QoL Survival Follow-Up Month 48	Number Analyzed	2 participants	7 participants
GHS/QoL Survival Follow-Up Month 48		58.33 (-259.32 to 375.99)	63.10 (47.77 to 78.42)
Physical Functioning Baseline	Number Analyzed	166 participants	161 participants
Physical Functioning Baseline		90.03 (87.82 to 92.24)	90.85 (88.53 to 93.17)
Physical Functioning Cycle 2 Day 1	Number Analyzed	164 participants	157 participants
Physical Functioning Cycle 2 Day 1		83.50 (80.79 to 86.21)	84.93 (82.55 to 87.31)
Physical Functioning Cycle 3 Day 1	Number Analyzed	152 participants	142 participants
Physical Functioning Cycle 3 Day 1		78.33 (75.19 to 81.48)	77.29 (74.04 to 80.54)
Physical Functioning Cycle 4 Day 1	Number Analyzed	152 participants	149 participants
Physical Functioning Cycle 4 Day 1		70.42 (67.06 to 73.77)	69.02 (65.52 to 72.51)
Physical Functioning Cycle 5 Day 1	Number Analyzed	146 participants	139 participants
Physical Functioning Cycle 5 Day 1		67.91 (64.18 to 71.65)	64.27 (60.40 to 68.13)
Physical Functioning Cycle 6 Day 1	Number Analyzed	134 participants	132 participants
Physical Functioning Cycle 6 Day 1		79.49 (76.38 to 82.60)	78.01 (74.81 to 81.20)
Physical Functioning Cycle 7 Day 1	Number Analyzed	122 participants	128 participants
Physical Functioning Cycle 7 Day 1		82.73 (79.76 to 85.71)	80.78 (77.96 to 83.60)
Physical Functioning Cycle 8 Day 1	Number Analyzed	119 participants	122 participants
Physical Functioning Cycle 8 Day 1		85.15 (82.75 to 87.56)	81.75 (78.59 to 84.90)
Physical Functioning Cycle 9 Day 1	Number Analyzed	121 participants	122 participants
Physical Functioning Cycle 9 Day 1		84.19 (81.57 to 86.81)	83.99 (81.36 to 86.62)
Physical Functioning Cycle 10 Day 1	Number Analyzed	114 participants	122 participants
Physical Functioning Cycle 10 Day 1		84.78 (82.16 to 87.40)	83.88 (81.21 to 86.55)
Physical Functioning Cycle 11 Day 1	Number Analyzed	119 participants	121 participants
Physical Functioning Cycle 11 Day 1		85.48 (83.18 to 87.77)	84.24 (81.33 to 87.15)
Physical Functioning Cycle 12 Day 1	Number Analyzed	119 participants	122 participants
Physical Functioning Cycle 12 Day 1		86.97 (84.66 to 89.29)	83.44 (80.55 to 86.34)
Physical Functioning Cycle 13 Day 1	Number Analyzed	119 participants	121 participants
Physical Functioning Cycle 13 Day 1		86.16 (83.40 to 88.93)	83.36 (80.27 to 86.45)
Physical Functioning Cycle 14 Day 1	Number Analyzed	119 participants	117 participants
Physical Functioning Cycle 14 Day 1		86.22 (83.56 to 88.88)	84.96 (82.18 to 87.73)
Physical Functioning Cycle 15 Day 1	Number Analyzed	112 participants	116 participants
Physical Functioning Cycle 15 Day 1		84.69 (81.67 to 87.71)	84.28 (81.23 to 87.34)
Physical Functioning Cycle 16 Day 1	Number Analyzed	111 participants	114 participants
Physical Functioning Cycle 16 Day 1		87.19 (84.34 to 90.04)	84.33 (81.37 to 87.29)
Physical Functioning Drug Completion/Early Discontinuation	Number Analyzed	130 participants	137 participants
Physical Functioning Drug Completion/Early Discontinuation		84.21 (81.31 to 87.10)	82.34 (79.24 to 85.43)
Physical Functioning Survival Follow-Up Month 3	Number Analyzed	131 participants	142 participants
Physical Functioning Survival Follow-Up Month 3		85.29 (82.65 to 87.93)	82.35 (79.29 to 85.41)
Physical Functioning Survival Follow-Up Month 6	Number Analyzed	125 participants	136 participants
Physical Functioning Survival Follow-Up Month 6		84.96 (82.15 to 87.77)	84.17 (81.11 to 87.22)
Physical Functioning Survival Follow-Up Month 9	Number Analyzed	116 participants	132 participants
Physical Functioning Survival Follow-Up Month 9		85.11 (82.46 to 87.77)	83.48 (80.01 to 86.96)
Physical Functioning Survival Follow-Up Month 12	Number Analyzed	111 participants	126 participants
Physical Functioning Survival Follow-Up Month 12		85.05 (81.79 to 88.30)	83.17 (79.67 to 86.68)
Physical Functioning Survival Follow-Up Month 18	Number Analyzed	102 participants	112 participants
Physical Functioning Survival Follow-Up Month 18		85.23 (81.63 to 88.82)	84.29 (80.85 to 87.72)
Physical Functioning Survival Follow-Up Month 24	Number Analyzed	82 participants	108 participants
Physical Functioning Survival Follow-Up Month 24		85.69 (82.05 to 89.33)	85.43 (81.67 to 89.20)
Physical Functioning Survival Follow-Up Month 30	Number Analyzed	65 participants	72 participants
Physical Functioning Survival Follow-Up Month 30		87.08 (83.41 to 90.75)	84.54 (80.35 to 88.73)
Physical Functioning Survival Follow-Up Month 36	Number Analyzed	62 participants	69 participants
Physical Functioning Survival Follow-Up Month 36		86.24 (81.63 to 90.84)	85.80 (81.87 to 89.73)
Physical Functioning Survival Follow-Up Month 48	Number Analyzed	2 participants	7 participants
Physical Functioning Survival Follow-Up Month 48		90.00 (-37.06 to 217.06)	88.57 (75.88 to 101.26)
Role Functioning Baseline	Number Analyzed	166 participants	161 participants
Role Functioning Baseline		88.86 (85.67 to 92.04)	89.44 (86.10 to 92.78)
Role Functioning Cycle 2 Day 1	Number Analyzed	164 participants	157 participants
Role Functioning Cycle 2 Day 1		80.39 (76.77 to 84.00)	77.18 (73.47 to 80.88)
Role Functioning Cycle 3 Day 1	Number Analyzed	152 participants	142 participants
Role Functioning Cycle 3 Day 1		70.39 (65.96 to 74.83)	69.48 (65.29 to 73.67)
Role Functioning Cycle 4 Day 1	Number Analyzed	153 participants	149 participants
Role Functioning Cycle 4 Day 1		61.11 (56.70 to 65.53)	56.60 (51.56 to 61.64)
Role Functioning Cycle 5 Day 1	Number Analyzed	146 participants	139 participants
Role Functioning Cycle 5 Day 1		56.06 (51.06 to 61.04)	51.08 (46.15 to 56.00)
Role Functioning Cycle 6 Day 1	Number Analyzed	134 participants	132 participants
Role Functioning Cycle 6 Day 1		66.17 (61.45 to 70.89)	62.88 (57.70 to 68.06)
Role Functioning Cycle 7 Day 1	Number Analyzed	122 participants	128 participants
Role Functioning Cycle 7 Day 1		73.77 (69.21 to 78.33)	69.92 (65.46 to 74.39)
Role Functioning Cycle 8 Day 1	Number Analyzed	119 participants	122 participants
Role Functioning Cycle 8 Day 1		77.59 (73.57 to 81.62)	72.95 (68.13 to 77.77)
Role Functioning Cycle 9 Day 1	Number Analyzed	121 participants	122 participants
Role Functioning Cycle 9 Day 1		77.13 (72.98 to 81.29)	74.32 (70.21 to 78.42)
Role Functioning Cycle 10 Day 1	Number Analyzed	114 participants	122 participants
Role Functioning Cycle 10 Day 1		78.51 (74.50 to 82.51)	75.27 (70.94 to 79.61)
Role Functioning Cycle 11 Day 1	Number Analyzed	119 participants	122 participants
Role Functioning Cycle 11 Day 1		79.97 (76.41 to 83.53)	75.68 (71.44 to 79.93)
Role Functioning Cycle 12 Day 1	Number Analyzed	119 participants	122 participants
Role Functioning Cycle 12 Day 1		81.79 (78.04 to 85.55)	75.14 (70.52 to 79.75)
Role Functioning Cycle 13 Day 1	Number Analyzed	119 participants	121 participants
Role Functioning Cycle 13 Day 1		81.79 (78.16 to 85.42)	74.38 (69.60 to 79.16)
Role Functioning Cycle 14 Day 1	Number Analyzed	119 participants	117 participants
Role Functioning Cycle 14 Day 1		80.81 (76.61 to 85.01)	75.50 (70.60 to 80.40)
Role Functioning Cycle 15 Day 1	Number Analyzed	112 participants	116 participants
Role Functioning Cycle 15 Day 1		79.02 (75.14 to 82.90)	77.59 (73.05 to 82.13)
Role Functioning Cycle 16 Day 1	Number Analyzed	111 participants	114 participants
Role Functioning Cycle 16 Day 1		83.03 (78.87 to 87.20)	78.65 (74.05 to 83.26)
Role Functioning Study Drug Completion/Early Discontinuation	Number Analyzed	130 participants	137 participants
		80.00 (76.07 to 83.93)	74.09 (69.37 to 78.81)
Role Functioning Survival Follow-Up Month 3	Number Analyzed	131 participants	142 participants
Role Functioning Survival Follow-Up Month 3		81.93 (78.24 to 85.63)	75.47 (70.97 to 79.97)
Role Functioning Survival Follow-Up Month 6	Number Analyzed	126 participants	136 participants
Role Functioning Survival Follow-Up Month 6		78.53 (74.01 to 83.06)	76.10 (71.38 to 80.83)
Role Functioning Survival Follow-Up Month 9	Number Analyzed	116 participants	132 participants
Role Functioning Survival Follow-Up Month 9		81.61 (77.90 to 85.32)	76.39 (71.36 to 81.42)
Role Functioning Survival Follow-Up Month 12	Number Analyzed	111 participants	126 participants
Role Functioning Survival Follow-Up Month 12		81.68 (77.46 to 85.91)	76.98 (71.47 to 82.50)
Role Functioning Survival Follow-Up Month 18	Number Analyzed	102 participants	112 participants
Role Functioning Survival Follow-Up Month 18		81.86 (76.88 to 86.85)	77.98 (72.77 to 83.18)
Role Functioning Survival Follow-Up Month 24	Number Analyzed	82 participants	108 participants
Role Functioning Survival Follow-Up Month 24		79.47 (73.62 to 85.32)	80.09 (75.03 to 85.15)
Role Functioning Survival Follow-Up Month 30	Number Analyzed	65 participants	72 participants
Role Functioning Survival Follow-Up Month 30		81.54 (75.51 to 87.56)	78.24 (71.20 to 85.28)
Role Functioning Survival Follow-Up Month 36	Number Analyzed	62 participants	69 participants
Role Functioning Survival Follow-Up Month 36		85.48 (79.88 to 91.09)	81.64 (75.23 to 88.05)
Role Functioning Survival Follow-Up Month 48	Number Analyzed	2 participants	7 participants
Role Functioning Survival Follow-Up Month 48		83.33 (-128.44 to 295.10)	76.19 (-228.44 to 195.10)

10.Secondary Outcome


Title	Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30
Description	Mean change from baseline score in function (role, physical) and globa...
Description	Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

All randomized participants with non-missing baseline assessment and at least one non-missing post-baseline assessment.


Arm/Group Title		Placebo and Chemotherapy	Atezolizumab and Chemotherapy
Arm/Group Description:		Participants received placebo match...	Participants received atezolizumab ...
Arm/Group Description:		Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed		167	161
Mean (95% Confidence Interval) Unit of Measure: Score on a 0-100 scale.
GHS/QoL Cycle 2 Day 1	Number Analyzed	164 participants	157 participants
GHS/QoL Cycle 2 Day 1		-4.62 (-7.89 to -1.36)	-7.91 (-11.09 to -4.72)
GHS/QoL Cycle 3 Day 1	Number Analyzed	152 participants	143 participants
GHS/QoL Cycle 3 Day 1		-12.72 (-16.34 to -9.10)	-17.07 (-21.15 to -13.00)
GHS/QoL Cycle 4 Day 1	Number Analyzed	153 participants	149 participants
GHS/QoL Cycle 4 Day 1		-14.49 (-18.35 to -10.62)	-19.80 (-23.50 to -16.09)
GHS/QoL Cycle Cycle 5 Day 1	Number Analyzed	147 participants	139 participants
GHS/QoL Cycle Cycle 5 Day 1		-17.06 (-21.18 to -12.94)	-26.02 (-30.34 to -21.70)
GHS/QoL Cycle 6 Day 1	Number Analyzed	134 participants	132 participants
GHS/QoL Cycle 6 Day 1		-2.49 (-6.70 to 1.72)	-8.78 (-12.71 to -4.84)
GHS/QoL Cycle 7 Day 1	Number Analyzed	122 participants	128 participants
GHS/QoL Cycle 7 Day 1		-0.61 (-4.64 to 3.41)	-5.40 (-9.15 to -1.66)
GHS/QoL Cycle 8 Day 1	Number Analyzed	119 participants	122 participants
GHS/QoL Cycle 8 Day 1		0.77 (-3.30 to 4.84)	-6.69 (-10.49 to -2.90)
GHS/QoL Cycle 9 Day 1	Number Analyzed	121 participants	121 participants
GHS/QoL Cycle 9 Day 1		-0.28 (-4.10 to 3.55)	-6.13 (-9.94 to -2.32)
GHS/QoL Cycle 10 Day 1	Number Analyzed	114 participants	122 participants
GHS/QoL Cycle 10 Day 1		-1.17 (-5.02 to 2.68)	-8.40 (-12.50 to -4.30)
GHS/QoL Cycle 11 Day 1	Number Analyzed	119 participants	122 participants
GHS/QoL Cycle 11 Day 1		0.35 (-3.42 to 4.13)	-7.04 (-11.11 to -2.96)
GHS/QoL Cycle 12 Day 1	Number Analyzed	119 participants	122 participants
GHS/QoL Cycle 12 Day 1		-0.63 (-4.64 to 3.38)	-6.56 (-10.48 to -2.64)
GHS/QoL Cycle 13 Day 1	Number Analyzed	119 participants	121 participants
GHS/QoL Cycle 13 Day 1		-1.26 (-5.19 to 2.67)	-5.85 (-9.83 to -1.88)
GHS/QoL Cycle 14 Day 1	Number Analyzed	119 participants	116 participants
GHS/QoL Cycle 14 Day 1		-1.05 (-4.95 to 2.85)	-7.47 (-11.44 to -3.50)
GHS/QoL Cycle 15 Day 1	Number Analyzed	112 participants	116 participants
GHS/QoL Cycle 15 Day 1		0.00 (-4.21 to 4.21)	-4.67 (-8.71 to -0.63)
GHS/QoL Cycle 16 Day 1	Number Analyzed	111 participants	114 participants
GHS/QoL Cycle 16 Day 1		2.10 (-1.66 to 5.86)	-3.73 (-7.93 to 0.48)
GHS/QoL Study Drug Completion/ Early Discontinuation	Number Analyzed	130 participants	137 participants
GHS/QoL Study Drug Completion/ Early Discontinuation		0.06 (-3.99 to 4.12)	-6.20 (-10.47 to -1.94)
GHS/QoL Survival Follow-Up Month 3	Number Analyzed	131 participants	142 participants
GHS/QoL Survival Follow-Up Month 3		0.64 (-3.54 to 4.81)	-6.57 (-10.28 to -2.87)
GHS/QoL Survival Follow-Up Month 6	Number Analyzed	125 participants	136 participants
GHS/QoL Survival Follow-Up Month 6		-2.00 (-6.16 to 2.16)	-3.37 (-7.24 to 0.50)
GHS/QoL Survival Follow-Up Month 9	Number Analyzed	116 participants	132 participants
GHS/QoL Survival Follow-Up Month 9		-0.93 (-5.26 to 3.39)	-4.42 (-8.07 to -0.77)
GHS/QoL Survival Follow-Up Month 12	Number Analyzed	111 participants	126 participants
GHS/QoL Survival Follow-Up Month 12		-1.65 (-5.91 to 2.61)	-4.50 (-8.67 to -0.32)
GHS/QoL Survival Follow-Up Month 18	Number Analyzed	102 participants	112 participants
GHS/QoL Survival Follow-Up Month 18		-0.98 (-6.10 to 4.14)	-4.17 (-8.67 to 0.34)
GHS/QoL Survival Follow-Up Month 24	Number Analyzed	83 participants	108 participants
GHS/QoL Survival Follow-Up Month 24		1.31 (-3.50 to 6.12)	-6.17 (-10.96 to -1.39)
GHS/QoL Survival Follow-Up Month 30	Number Analyzed	65 participants	72 participants
GHS/QoL Survival Follow-Up Month 30		-2.18 (-8.05 to 3.69)	-9.14 (-14.26 to -4.03)
GHS/QoL Survival Follow-Up Month 36	Number Analyzed	62 participants	69 participants
GHS/QoL Survival Follow-Up Month 36		-1.08 (-6.42 to 4.27)	-5.56 (-11.22 to 0.11)
GHS/QoL Survival Follow-Up Month 48	Number Analyzed	2 participants	7 participants
GHS/QoL Survival Follow-Up Month 48		-25.00 (-342.66 to 292.66)	-21.43 (-37.99 to -4.86)
Physical Functioning Cycle 2 Day 1	Number Analyzed	163 participants	157 participants
Physical Functioning Cycle 2 Day 1		-6.37 (-8.58 to -4.16)	-5.73 (-8.18 to -3.29)
Physical Functioning Cycle 3 Day 1	Number Analyzed	151 participants	142 participants
Physical Functioning Cycle 3 Day 1		-12.17 (-15.43 to -8.92)	-12.90 (-16.62 to -9.17)
Physical Functioning Cycle 4 Day 1	Number Analyzed	151 participants	149 participants
Physical Functioning Cycle 4 Day 1		-19.48 (-22.51 to -16.45)	-21.68 (-25.66 to -17.70)
Physical Functioning Cycle 5 Day 1	Number Analyzed	145 participants	139 participants
Physical Functioning Cycle 5 Day 1		-21.59 (-25.17 to -18.01)	-26.43 (-30.61 to -22.25)
Physical Functioning Cycle 6 Day 1	Number Analyzed	134 participants	132 participants
Physical Functioning Cycle 6 Day 1		-10.20 (-13.46 to -6.94)	-12.20 (-15.39 to -9.00)
Physical Functioning Cycle 7 Day 1	Number Analyzed	122 participants	128 participants
Physical Functioning Cycle 7 Day 1		-7.43 (-10.48 to -4.38)	-8.96 (-12.22 to -5.69)
Physical Functioning Cycle 8 Day 1	Number Analyzed	119 participants	122 participants
Physical Functioning Cycle 8 Day 1		-4.80 (-7.52 to -2.09)	-7.70 (-11.21 to -4.19)
Physical Functioning Cycle 9 Day 1	Number Analyzed	121 participants	122 participants
Physical Functioning Cycle 9 Day 1		-5.40 (-8.20 to -2.60)	-5.74 (-9.04 to -2.44)
Physical Functioning Cycle 10 Day 1	Number Analyzed	114 participants	122 participants
Physical Functioning Cycle 10 Day 1		-4.87 (-7.82 to -1.92)	-6.17 (-9.25 to -3.10)
Physical Functioning Cycle 11 Day 1	Number Analyzed	119 participants	121 participants
Physical Functioning Cycle 11 Day 1		-3.99 (-6.77 to -1.21)	-5.73 (-9.09 to -2.37)
Physical Functioning Cycle 12 Day 1	Number Analyzed	119 participants	122 participants
Physical Functioning Cycle 12 Day 1		-2.59 (-5.39 to 0.21)	-6.61 (-9.60 to -3.62)
Physical Functioning Cycle 13 Day 1	Number Analyzed	119 participants	121 participants
Physical Functioning Cycle 13 Day 1		-3.63 (-6.77 to -0.48)	-6.72 (-10.01 to -3.43)
Physical Functioning Cycle 14 Day 1	Number Analyzed	119 participants	117 participants
Physical Functioning Cycle 14 Day 1		-3.42 (-6.33 to -0.51)	-5.07 (-8.25 to -1.89)
Physical Functioning Cycle 15 Day 1	Number Analyzed	112 participants	116 participants
Physical Functioning Cycle 15 Day 1		-4.24 (-7.59 to -0.89)	-5.89 (-9.22 to -2.56)
Physical Functioning Cycle 16 Day 1	Number Analyzed	111 participants	114 participants
Physical Functioning Cycle 16 Day 1		-2.42 (-5.70 to 0.86)	-5.79 (-9.05 to -2.53)
Physical Functioning Study Drug Completion/Early Discontinuation	Number Analyzed	130 participants	137 participants
		-5.58 (-8.88 to -2.27)	-8.66 (-12.12 to -5.21)
Physical Functioning Survival Follow-Up Month 3	Number Analyzed	131 participants	142 participants
Physical Functioning Survival Follow-Up Month 3		-4.16 (-6.77 to -1.55)	-8.54 (-11.83 to -5.26)
Physical Functioning Survival Follow-Up Month 6	Number Analyzed	125 participants	136 participants
Physical Functioning Survival Follow-Up Month 6		-5.21 (-7.90 to -2.53)	-6.91 (-10.10 to -3.72)
Physical Functioning Survival Follow-Up Month 9	Number Analyzed	116 participants	132 participants
Physical Functioning Survival Follow-Up Month 9		-3.97 (-6.65 to -1.28)	-7.78 (-11.20 to -4.36)
Physical Functioning Survival Follow-Up Month 12	Number Analyzed	111 participants	126 participants
Physical Functioning Survival Follow-Up Month 12		-4.43 (-7.23 to -1.62)	-7.46 (-11.07 to -3.85)
Physical Functioning Survival Follow-Up Month 18	Number Analyzed	102 participants	112 participants
Physical Functioning Survival Follow-Up Month 18		-4.90 (-8.58 to -1.22)	-6.61 (-10.17 to -3.05)
Physical Functioning Survival Follow-Up Month 24	Number Analyzed	82 participants	108 participants
Physical Functioning Survival Follow-Up Month 24		-4.07 (-7.64 to -0.49)	-6.30 (-9.94 to -2.65)
Physical Functioning Survival Follow-Up Month 30	Number Analyzed	65 participants	72 participants
Physical Functioning Survival Follow-Up Month 30		-3.36 (-6.90 to 0.18)	-10.46 (-14.68 to -6.25)
Physical Functioning Survival Follow-Up Month 36	Number Analyzed	62 participants	69 participants
Physical Functioning Survival Follow-Up Month 36		-4.06 (-8.93 to 0.81)	-8.70 (-12.47 to -4.92)
Physical Functioning Survival Follow-Up Month 48	Number Analyzed	2 participants	7 participants
Physical Functioning Survival Follow-Up Month 48		-3.33 (-45.69 to 39.02)	-11.43 (-24.12 to 1.26)
Role Functioning Cycle 2 Day 1	Number Analyzed	163 participants	157 participants
Role Functioning Cycle 2 Day 1		-8.08 (-12.05 to -4.11)	-12.42 (-16.70 to -8.14)
Role Functioning Cycle 3 Day 1	Number Analyzed	151 participants	142 participants
Role Functioning Cycle 3 Day 1		-19.54 (-24.57 to -14.50)	-19.84 (-24.92 to -14.76)
Role Functioning Cycle 4 Day 1	Number Analyzed	152 participants	149 participants
Role Functioning Cycle 4 Day 1		-28.29 (-33.49 to -23.09)	-33.56 (-39.19 to -27.93)
Role Functioning Cycle 5 Day 1	Number Analyzed	145 participants	139 participants
Role Functioning Cycle 5 Day 1		-32.99 (-38.45 to -27.53)	-38.97 (-44.44 to -33.50)
Role Functioning Cycle 6 Day 1	Number Analyzed	134 participants	132 participants
Role Functioning Cycle 6 Day 1		-22.39 (-27.55 to -17.23)	-26.14 (-31.45 to -20.83)
Role Functioning Cycle 7 Day 1	Number Analyzed	122 participants	128 participants
Role Functioning Cycle 7 Day 1		-14.21 (-19.06 to -9.35)	-18.36 (-23.36 to -13.36)
Role Functioning Cycle 8 Day 1	Number Analyzed	119 participants	122 participants
Role Functioning Cycle 8 Day 1		-10.50 (-15.16 to -5.85)	-14.89 (-20.37 to -9.41)
Role Functioning Cycle 9 Day 1	Number Analyzed	121 participants	122 participants
Role Functioning Cycle 9 Day 1		-10.74 (-15.21 to -6.28)	-13.80 (-19.13 to -8.47)
Role Functioning Cycle 10 Day 1	Number Analyzed	114 participants	122 participants
Role Functioning Cycle 10 Day 1		-9.36 (-13.94 to -4.77)	-13.39 (-18.13 to -8.64)
Role Functioning Cycle 11 Day 1	Number Analyzed	119 participants	122 participants
Role Functioning Cycle 11 Day 1		-8.26 (-12.65 to -3.88)	-12.98 (-17.53 to -8.43)
Role Functioning Cycle 12 Day 1	Number Analyzed	119 participants	122 participants
Role Functioning Cycle 12 Day 1		-6.86 (-11.40 to -2.33)	-13.52 (-18.06 to -8.99)
Role Functioning Cycle 13 Day 1	Number Analyzed	119 participants	121 participants
Role Functioning Cycle 13 Day 1		-6.30 (-10.16 to -2.44)	-14.46 (-19.69 to -9.24)
Role Functioning Cycle 14 Day 1	Number Analyzed	119 participants	117 participants
Role Functioning Cycle 14 Day 1		-7.28 (-11.77 to -2.80)	-13.82 (-18.80 to -8.84)
Role Functioning Cycle 15 Day 1	Number Analyzed	112 participants	116 participants
Role Functioning Cycle 15 Day 1		-8.63 (-13.14 to -4.12)	-11.78 (-16.96 to -6.60)
Role Functioning Cycle 16 Day 1	Number Analyzed	111 participants	114 participants
Role Functioning Cycle 16 Day 1		-4.65 (-9.70 to 0.39)	-10.82 (-15.56 to -6.07)
Role Functioning Study Drug Completion/Early Discontinuation	Number Analyzed	130 participants	137 participants
		-8.46 (-13.54 to -3.38)	-16.42 (-21.64 to -11.21)
Role Functioning Survival Follow-Up Month 3	Number Analyzed	131 participants	142 participants
Role Functioning Survival Follow-Up Month 3		-5.98 (-10.57 to -1.39)	-14.44 (-19.35 to -9.53)
Role Functioning Survival Follow-Up Month 6	Number Analyzed	125 participants	136 participants
Role Functioning Survival Follow-Up Month 6		-10.67 (-15.66 to -5.68)	-13.97 (-18.84 to -9.10)
Role Functioning Survival Follow-Up Month 9	Number Analyzed	116 participants	132 participants
Role Functioning Survival Follow-Up Month 9		-7.61 (-12.23 to -3.00)	-13.76 (-18.45 to -9.08)
Role Functioning Survival Follow-Up Month 12	Number Analyzed	111 participants	126 participants
Role Functioning Survival Follow-Up Month 12		-7.66 (-11.90 to -3.41)	-12.83 (-18.13 to -7.53)
Role Functioning Survival Follow-Up Month 18	Number Analyzed	102 participants	112 participants
Role Functioning Survival Follow-Up Month 18		-7.03 (-12.54 to -1.51)	-12.05 (-17.15 to -6.95)
Role Functioning Survival Follow-Up Month 24	Number Analyzed	82 participants	108 participants
Role Functioning Survival Follow-Up Month 24		-9.96 (-15.85 to -4.07)	-10.96 (-16.19 to -5.72)
Role Functioning Survival Follow-Up Month 30	Number Analyzed	65 participants	72 participants
Role Functioning Survival Follow-Up Month 30		-8.72 (-15.45 to -1.98)	-16.44 (-23.12 to -9.75)
Role Functioning Survival Follow-Up Month 36	Number Analyzed	62 participants	69 participants
Role Functioning Survival Follow-Up Month 36		-5.65 (-12.45 to 1.16)	-12.56 (-18.94 to -6.18)
Role Functioning Survival Follow-Up Month 48	Number Analyzed	2 participants	7 participants
Role Functioning Survival Follow-Up Month 48		-16.67 (-228.44 to 195.10)	-21.43 (-47.70 to 4.84)

11.Secondary Outcome


Title	Percentage of Participants With at Least One Adverse Events (AEs)
Description	Percentage of participants with at least one adverse event.
Description	Percentage of participants with at least one adverse event.
Time Frame	From randomization and up to study final analysis data cut off on 28 September 2022.

Outcome Measure Data

Analysis Population Description

Safety population is defined as all participants who received any dose of study medication.


Arm/Group Title	Atezolizumab and Chemotherapy	Placebo and Chemotherapy
Arm/Group Description:	Participants received atezolizumab ...	Participants received placebo match...
Arm/Group Description:	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.
Overall Number of Participants Analyzed	164	167
Measure Type: Number Unit of Measure: Percentage of participants
	100	100

12.Secondary Outcome


Title	Minimum Observed Serum Atezolizumab Concentration (Cmin)
Description	Minimum observed serum atezolizumab concentration.
Description	Minimum observed serum atezolizumab concentration.
Time Frame	Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)

Outcome Measure Data

Analysis Population Description

The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.


Arm/Group Title	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received atezolizumab ...
Arm/Group Description:	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	164
Mean (Standard Deviation) Unit of Measure: µg/mL
Cycle 2 Day 1	142 (54.3)
Cycle 3 Day 1	189 (64.2)
Cycle 4 Day 1	207 (77.3)
Cycle 6 Day 1	78.7 (50.3)
Cycle 8 Day 1	204 (62.7)
Cycle 12 Day 1	267 (81.1)
Cycle 16 Day 1	303 (89.1)

13.Secondary Outcome


Title	Maximum Observed Serum Atezolizumab Concentration (Cmax)
Description	Maximum observed atezolizumab concentration (Cmax).
Description	Maximum observed atezolizumab concentration (Cmax).
Time Frame	Day 1 of Cycle 1 post dose (cycle length = 28 days)

Outcome Measure Data

Analysis Population Description

The pharmacokinetic-evaluable population is defined as all participants who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples.


Arm/Group Title	Atezolizumab and Chemotherapy
Arm/Group Description:	Participants received atezolizumab ...
Arm/Group Description:	Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed	164
Mean (Standard Deviation) Unit of Measure: µg/mL
	334 (63.3)

14.Secondary Outcome


Title	Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Description	Percentage of participants with anti-drug antibodies (ADAs) to atezoli...
Description	Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.
Time Frame	Baseline up to approximately 20 months

Outcome Measure Data

Analysis Population Description

The anti-drug antibodies (ADA)-evaluable population is defined as all participants treated with atezolizumab who have at least one post-baseline ADA result.


Arm/Group Title		Atezolizumab and Chemotherapy
Arm/Group Description:		Participants received atezolizumab ...
Arm/Group Description:		Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Overall Number of Participants Analyzed		162
Measure Type: Number Unit of Measure: Percentage of participants
Baseline evaluable participants	Number Analyzed	162 participants
Baseline evaluable participants		2.5
Post-baseline evaluable participants	Number Analyzed	157 participants
Post-baseline evaluable participants		13.4

Adverse Events

Time Frame	From the first study drug and up to study final analysis data cut off on 28 September 2022, up to approximately 62 months.
Adverse Event Reporting Description	Safety population included participants who received any amount of any study drug.

Arm/Group Title	Placebo and Chemotherapy		Atezolizumab and Chemotherapy
Arm/Group Description	Participants received placebo match...		Participants received atezolizumab ...
Arm/Group Description	Participants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will continue to be followed after surgery.		Participants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
All-Cause Mortality
	Placebo and Chemotherapy		Atezolizumab and Chemotherapy
	Affected / at Risk (%)		Affected / at Risk (%)
Total	28/167 (16.77%)		16/164 (9.76%)
Serious Adverse Events Serious Adverse Events
	Placebo and Chemotherapy		Atezolizumab and Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/167 (21.56%)		59/164 (35.98%)
Blood and lymphatic system disorders
Anaemia ^† 1	3/167 (1.80%)	3	1/164 (0.61%)	1
Febrile neutropenia ^† 1	13/167 (7.78%)	14	16/164 (9.76%)	18
Neutropenia ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Cardiac disorders
Cardiac failure ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Endocrine disorders
Hypopituitarism ^† 1	1/167 (0.60%)	1	1/164 (0.61%)	1
Gastrointestinal disorders
Abdominal distension ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Abdominal pain ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Colitis ^† 1	0/167 (0.00%)	0	2/164 (1.22%)	2
Diarrhoea ^† 1	0/167 (0.00%)	0	2/164 (1.22%)	2
Intestinal obstruction ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Nausea ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Obstructive pancreatitis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Small intestinal obstruction ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Stomatitis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Vomiting ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
General disorders
Asthenia ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
General physical health deterioration ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Impaired healing ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Malaise ^† 1	1/167 (0.60%)	2	0/164 (0.00%)	0
Pyrexia ^† 1	0/167 (0.00%)	0	4/164 (2.44%)	4
Hepatobiliary disorders
Hepatic function abnormal ^† 1	0/167 (0.00%)	0	3/164 (1.83%)	3
Immune system disorders
Drug hypersensitivity ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Infections and infestations
Abdominal infection ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Bacillus bacteraemia ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Candida infection ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Cellulitis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Diverticulitis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Encephalitis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Gastroenteritis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Infection ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Influenza ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Mastitis ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Neutropenic sepsis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Periorbital cellulitis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Pneumocystis jirovecii pneumonia ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Pneumonia ^† 1	1/167 (0.60%)	1	6/164 (3.66%)	6
Pyelonephritis acute ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Respiratory tract infection ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Sepsis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Staphylococcal bacteraemia ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Upper respiratory tract infection ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Urinary tract infection ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	4
Urosepsis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Vascular device infection ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Injury, poisoning and procedural complications
Fracture ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Infusion related reaction ^† 1	1/167 (0.60%)	2	1/164 (0.61%)	1
Pneumonitis chemical ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Post procedural haematoma ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Road traffic accident ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Wound dehiscence ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Aspartate aminotransferase increased ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Neutrophil count decreased ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Platelet count decreased ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Metabolism and nutrition disorders
Dehydration ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Diabetes mellitus ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Hyponatraemia ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Vitamin D deficiency ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Nervous system disorders
Guillain-Barre syndrome ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Peripheral motor neuropathy ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Peripheral sensory neuropathy ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Polyneuropathy ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Syncope ^† 1	0/167 (0.00%)	0	3/164 (1.83%)	3
Renal and urinary disorders
Renal infarct ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Haemoptysis ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Interstitial lung disease ^† 1	1/167 (0.60%)	1	1/164 (0.61%)	1
Pneumonitis ^† 1	2/167 (1.20%)	2	1/164 (0.61%)	1
Pneumothorax ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Pulmonary embolism ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Respiratory failure ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Skin and subcutaneous tissue disorders
Dermatitis ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Dermatomyositis ^† 1	0/167 (0.00%)	0	1/164 (0.61%)	1
Vascular disorders
Embolism ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
Thrombosis ^† 1	1/167 (0.60%)	1	0/164 (0.00%)	0
1 Term from vocabulary, MedDRA version 25.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo and Chemotherapy		Atezolizumab and Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	167/167 (100.00%)		162/164 (98.78%)
Blood and lymphatic system disorders
Anaemia ^† 1	65/167 (38.92%)	80	64/164 (39.02%)	89
Leukopenia ^† 1	17/167 (10.18%)	29	23/164 (14.02%)	46
Neutropenia ^† 1	59/167 (35.33%)	123	65/164 (39.63%)	141
Thrombocytopenia ^† 1	5/167 (2.99%)	6	13/164 (7.93%)	16
Endocrine disorders
Hypothyroidism ^† 1	0/167 (0.00%)	0	22/164 (13.41%)	22
Eye disorders
Dry eye ^† 1	6/167 (3.59%)	6	13/164 (7.93%)	13
Lacrimation increased ^† 1	18/167 (10.78%)	18	18/164 (10.98%)	21
Vision blurred ^† 1	11/167 (6.59%)	12	16/164 (9.76%)	16
Gastrointestinal disorders
Abdominal pain ^† 1	16/167 (9.58%)	21	23/164 (14.02%)	29
Abdominal pain upper ^† 1	13/167 (7.78%)	16	21/164 (12.80%)	23
Constipation ^† 1	55/167 (32.93%)	64	51/164 (31.10%)	74
Diarrhoea ^† 1	74/167 (44.31%)	117	74/164 (45.12%)	110
Dry mouth ^† 1	5/167 (2.99%)	6	10/164 (6.10%)	11
Dyspepsia ^† 1	21/167 (12.57%)	23	19/164 (11.59%)	22
Nausea ^† 1	110/167 (65.87%)	189	108/164 (65.85%)	218
Stomatitis ^† 1	29/167 (17.37%)	32	40/164 (24.39%)	48
Vomiting ^† 1	51/167 (30.54%)	70	63/164 (38.41%)	105
General disorders
Asthenia ^† 1	36/167 (21.56%)	40	42/164 (25.61%)	66
Fatigue ^† 1	65/167 (38.92%)	86	65/164 (39.63%)	94
Malaise ^† 1	17/167 (10.18%)	18	15/164 (9.15%)	35
Mucosal inflammation ^† 1	15/167 (8.98%)	19	18/164 (10.98%)	24
Oedema peripheral ^† 1	24/167 (14.37%)	27	24/164 (14.63%)	30
Pain ^† 1	11/167 (6.59%)	11	20/164 (12.20%)	22
Pyrexia ^† 1	21/167 (12.57%)	25	37/164 (22.56%)	55
Infections and infestations
Nasopharyngitis ^† 1	14/167 (8.38%)	17	23/164 (14.02%)	29
Paronychia ^† 1	21/167 (12.57%)	21	19/164 (11.59%)	20
Upper respiratory tract infection ^† 1	16/167 (9.58%)	16	23/164 (14.02%)	30
Urinary tract infection ^† 1	11/167 (6.59%)	11	18/164 (10.98%)	25
Injury, poisoning and procedural complications
Infusion related reaction ^† 1	10/167 (5.99%)	16	16/164 (9.76%)	28
Procedural pain ^† 1	2/167 (1.20%)	2	14/164 (8.54%)	17
Radiation skin injury ^† 1	0/167 (0.00%)	0	32/164 (19.51%)	32
Investigations
Alanine aminotransferase increased ^† 1	35/167 (20.96%)	53	39/164 (23.78%)	63
Aspartate aminotransferase increased ^† 1	28/167 (16.77%)	44	37/164 (22.56%)	64
Blood alkaline phosphatase increased ^† 1	4/167 (2.40%)	4	14/164 (8.54%)	19
Blood lactate dehydrogenase increased ^† 1	7/167 (4.19%)	7	10/164 (6.10%)	11
Neutrophil count decreased ^† 1	30/167 (17.96%)	67	29/164 (17.68%)	60
Weight decreased ^† 1	8/167 (4.79%)	8	15/164 (9.15%)	17
White blood cell count decreased ^† 1	15/167 (8.98%)	35	14/164 (8.54%)	33
Metabolism and nutrition disorders
Decreased appetite ^† 1	33/167 (19.76%)	36	28/164 (17.07%)	37
Hypokalaemia ^† 1	7/167 (4.19%)	9	12/164 (7.32%)	24
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	42/167 (25.15%)	61	50/164 (30.49%)	76
Back pain ^† 1	20/167 (11.98%)	24	24/164 (14.63%)	27
Bone pain ^† 1	11/167 (6.59%)	12	13/164 (7.93%)	14
Myalgia ^† 1	40/167 (23.95%)	49	51/164 (31.10%)	86
Pain in extremity ^† 1	19/167 (11.38%)	26	27/164 (16.46%)	36
Nervous system disorders
Dizziness ^† 1	15/167 (8.98%)	16	20/164 (12.20%)	33
Dysgeusia ^† 1	25/167 (14.97%)	27	16/164 (9.76%)	20
Headache ^† 1	36/167 (21.56%)	46	51/164 (31.10%)	86
Neuropathy peripheral ^† 1	34/167 (20.36%)	42	40/164 (24.39%)	48
Paraesthesia ^† 1	19/167 (11.38%)	22	12/164 (7.32%)	13
Peripheral sensory neuropathy ^† 1	42/167 (25.15%)	45	58/164 (35.37%)	65
Polyneuropathy ^† 1	14/167 (8.38%)	15	10/164 (6.10%)	10
Taste disorder ^† 1	13/167 (7.78%)	13	10/164 (6.10%)	11
Psychiatric disorders
Anxiety ^† 1	11/167 (6.59%)	11	12/164 (7.32%)	13
Depression ^† 1	6/167 (3.59%)	6	11/164 (6.71%)	11
Insomnia ^† 1	29/167 (17.37%)	30	49/164 (29.88%)	61
Reproductive system and breast disorders
Breast pain ^† 1	15/167 (8.98%)	15	17/164 (10.37%)	19
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	32/167 (19.16%)	39	41/164 (25.00%)	52
Dyspnoea ^† 1	20/167 (11.98%)	22	23/164 (14.02%)	25
Epistaxis ^† 1	24/167 (14.37%)	26	25/164 (15.24%)	26
Oropharyngeal pain ^† 1	18/167 (10.78%)	19	19/164 (11.59%)	20
Rhinorrhoea ^† 1	0/167 (0.00%)	0	10/164 (6.10%)	12
Skin and subcutaneous tissue disorders
Alopecia ^† 1	129/167 (77.25%)	132	125/164 (76.22%)	127
Dermatitis acneiform ^† 1	10/167 (5.99%)	10	6/164 (3.66%)	8
Dry skin ^† 1	13/167 (7.78%)	13	18/164 (10.98%)	20
Erythema ^† 1	5/167 (2.99%)	5	15/164 (9.15%)	17
Nail discolouration ^† 1	29/167 (17.37%)	29	26/164 (15.85%)	28
Nail disorder ^† 1	10/167 (5.99%)	10	21/164 (12.80%)	22
Pruritus ^† 1	25/167 (14.97%)	31	36/164 (21.95%)	49
Rash ^† 1	42/167 (25.15%)	53	52/164 (31.71%)	68
Rash maculo-papular ^† 1	12/167 (7.19%)	14	12/164 (7.32%)	12
Vascular disorders
Hot flush ^† 1	17/167 (10.18%)	20	28/164 (17.07%)	32
Hypertension ^† 1	17/167 (10.18%)	29	15/164 (9.15%)	27
1 Term from vocabulary, MedDRA version 25.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of these secondary endpoints are descriptive in nature.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Communications
Organization:	Hoffmann-La Roche
Phone:	800-821-8590
EMail:	genentech@druginfo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.

Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.

Layout table for additonal information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT03197935
Other Study ID Numbers:	WO39392 2016-004734-22 ( EudraCT Number )
First Submitted:	June 21, 2017
First Posted:	June 23, 2017
Results First Submitted:	March 29, 2021
Results First Posted:	June 2, 2021
Last Update Posted:	October 26, 2023

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