The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy (KATE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924883
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : February 12, 2019
Last Update Posted : February 17, 2021
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 Metastatic Breast Cancer
Interventions Drug: Atezolizumab
Drug: Trastuzumab emtansine
Other: Placebo
Enrollment 202
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo
Hide Arm/Group Description Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months) Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Period Title: Overall Study
Started 133 69
Completed 0 0
Not Completed 133 69
Reason Not Completed
Death             39             20
Lost to Follow-up             1             0
Symptomatic Deterioration/ Clinical Progression             0             1
Protocol Violation             1             0
Withdrawal by Subject             22             16
Progressive Disease             1             0
Study Terminated by Sponsor             69             32
Arm/Group Title Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo Total
Hide Arm/Group Description Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months) Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months) Total of all reporting groups
Overall Number of Baseline Participants 133 69 202
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 69 participants 202 participants
53.7  (9.9) 54.4  (10.9) 53.9  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 69 participants 202 participants
Female
131
  98.5%
69
 100.0%
200
  99.0%
Male
2
   1.5%
0
   0.0%
2
   1.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 69 participants 202 participants
Hispanic or Latino
10
   7.5%
1
   1.4%
11
   5.4%
Not Hispanic or Latino
114
  85.7%
66
  95.7%
180
  89.1%
Unknown or Not Reported
9
   6.8%
2
   2.9%
11
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 69 participants 202 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
49
  36.8%
23
  33.3%
72
  35.6%
Native Hawaiian or Other Pacific Islander
1
   0.8%
0
   0.0%
1
   0.5%
Black or African American
5
   3.8%
1
   1.4%
6
   3.0%
White
72
  54.1%
44
  63.8%
116
  57.4%
More than one race
1
   0.8%
0
   0.0%
1
   0.5%
Unknown or Not Reported
5
   3.8%
1
   1.4%
6
   3.0%
Region  
Measure Type: Number
Unit of measure:  Number of Participants
 Number Analyzed 133 participants 69 participants 202 participants
USA 21 11 32
Western Europe 50 26 76
Rest of the World 62 32 94
Programmed Cell-Death Ligand 1 Immunohistochemistry status  
Measure Type: Number
Unit of measure:  Number of Participants
 Number Analyzed 133 participants 69 participants 202 participants
PD-L1 positive 57 27 84
PD-L1 negative 76 42 118
1.Primary Outcome
Title Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Hide Description PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.
Time Frame Baseline up to approximately 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 69 133
Median (95% Confidence Interval)
Unit of Measure: months
6.8
(4.0 to 11.1)
8.2
(5.8 to 10.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trastuzumab Emtansine + Placebo, Trastuzumab Emtansine + Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3332
Comments [Not Specified]
Method Log Rank
Comments The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval 95%
0.55 to 1.23
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame Baseline up to study completion, approximately 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 68 132
Measure Type: Number
Unit of Measure: percentage of participants
97.0 99.2
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death from any cause.
Time Frame Baseline up to study completion or death, whichever occurs first, approximately 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 69 133
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and corresponding 95% CI could not be estimated as too few patients had an event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trastuzumab Emtansine + Placebo, Trastuzumab Emtansine + Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2934
Comments [Not Specified]
Method Log Rank
Comments The 2-sided log-rank test was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval 95%
0.42 to 1.30
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Objective Response (OR) as Determined by Investigator's Tumor Assessment Using RECIST v1.1
Hide Description An OR was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.
Time Frame Baseline up to approximately 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization. In Participants with baseline measurable disease were considered for OR. In the atezolizumab arm, one patient was not ORR evaluable.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 69 132
Measure Type: Number
Unit of Measure: Percentage of participants
43.5 45.5
5.Secondary Outcome
Title Duration of OR as Determined by Investigator's Tumor Assessment Using RECIST v1.1
Hide Description Duration of OR was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.
Time Frame Baseline up to approximately 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants with OR were considered for duration of OR.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 69 133
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(9.9 to NA)
NA [1] 
(7.1 to NA)
[1]
Median and upper bound of 95% CI could not be estimated as too few patients had an event.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trastuzumab Emtansine + Placebo, Trastuzumab Emtansine + Atezolizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6099
Comments [Not Specified]
Method Log Rank
Comments Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.26
Confidence Interval 95%
0.52 to 3.03
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine
Hide Description Average post infusion Trastuzumab Emtansine concentration
Time Frame Pre-infusion (0 hour [h]), 30 minutes (min) after end of infusion (EOI) (over 90 min) on Day 1 Cycles 1 and 4; pre-infusion (0 h) on Day 1 Cycle 2 (each cycle = 21 days); at any time during study treatment/early discontinuation visit (approx. 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 110 50
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
63.9
(116.9%)
73.2
(47.5%)
7.Secondary Outcome
Title Cmax of Deacetyl Mercapto 1-Oxopropyl Maytansine (DM1)
Hide Description Average post infusion Deacetyl Mercapto 1-Oxopropyl Maytansine concentration of trastuzumab emtansine infusion
Time Frame Pre-infusion (0 h) on Day 1 Cycle 1 and 30 min after EOI (over 90 min) on Day 1 Cycles 1 and 4 (each cycle = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 24 37
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
3.19
(84.7%)
4.21
(89.5%)
8.Secondary Outcome
Title Cmax of Total Trastuzumab
Hide Description [Not Specified]
Time Frame Pre-infusion (0 h), 30 min after EOI (over 90 min) on Day 1 Cycles 1 and 4; pre-infusion (0 h) on Day 1 Cycle 2 (each cycle = 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 50 110
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
86.5
(26.4%)
79.5
(58.3%)
9.Secondary Outcome
Title Cmax of Atezolizumab
Hide Description Average post infusion atezolizumab concentration
Time Frame Pre-infusion (0 h), 30 min after EOI (over 60 min) on Day 1 Cycles 1 and 4; pre-infusion (0 h) on Day 1 Cycles 2, 3, 8, and every 8 cycles thereafter (each cycle=21 days) up to 120 days after treatment completion/early discontinuation (approx. 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.
Arm/Group Title Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 98
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
626
(23.0%)
10.Secondary Outcome
Title Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to Atezolizumab
Hide Description ATAs are antibodies that inactivate the therapeutic effects of Atezolizumab. Patients are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater (i.e., ≥ 0.60 titer units) than the titer of the baseline sample (treatment-enhanced ATA response).
Time Frame Pre-infusion (0 h) on Day 1 Cycles 1, 2, 3, 4, 8, and every 8 cycles thereafter (each cycle = 21 days) up to 120 days after treatment completion or early discontinuation (approximately 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included a patient with an ATA assay result from at least one post-baseline sample.
Arm/Group Title Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 131
Measure Type: Number
Unit of Measure: Percentage of participants
18.3
11.Secondary Outcome
Title Percentage of Participants With ATAs to Trastuzumab Emtansine
Hide Description ATAs are antibodies that inactivate the therapeutic effects of Trastuzumab Emtansine. Patients are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater (i.e., ≥ 0.60 titer units) than the titer of the baseline sample (treatment-enhanced ATA response).
Time Frame Pre-infusion (0 h) on Day 1 Cycles 1 and 4 (each cycle = 21 days); and at any time during study treatment/early discontinuation visit (approximately 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included a patient with an ATA assay result from at least one post-baseline sample
Arm/Group Title Trastuzumab Emtansine + Placebo Trastuzumab Emtansine + Atezolizumab
Hide Arm/Group Description:
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months)
Overall Number of Participants Analyzed 60 129
Measure Type: Number
Unit of Measure: Percentage of Participants
0 2.3
Time Frame Baseline up to study completion, approximately 40 months
Adverse Event Reporting Description The safety population is defined as all participants who received at least one dose of the study medication.
 
Arm/Group Title Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo
Hide Arm/Group Description Atezolizumab 1200 milligrams (mg) intravenous (IV) infusion followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor (up to study duration of approximately 40 months) Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor (up to study duration of approximately 40 months)
All-Cause Mortality
Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   42/133 (31.58%)      22/67 (32.84%)    
Hide Serious Adverse Events
Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/133 (39.10%)      16/67 (23.88%)    
Blood and lymphatic system disorders     
Thrombocytopenia † 1  2/133 (1.50%)  2 0/67 (0.00%)  0
Anaemia † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Disseminated intravascular coagulation † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Cardiac disorders     
Atrial thrombosis † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Cardiac failure † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Ear and labyrinth disorders     
Vertigo † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Gastrointestinal disorders     
Vomiting † 1  3/133 (2.26%)  3 0/67 (0.00%)  0
Nausea † 1  1/133 (0.75%)  1 1/67 (1.49%)  1
Colitis † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Constipation † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Enteritis † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Abdominal pain † 1  0/133 (0.00%)  0 2/67 (2.99%)  2
Intra-abdominal haemorrhage † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
General disorders     
Asthenia † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Fatigue † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Influenza like illness † 1  2/133 (1.50%)  2 1/67 (1.49%)  1
Malaise † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Non-cardiac chest pain † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Pyrexia † 1  10/133 (7.52%)  12 0/67 (0.00%)  0
Immune system disorders     
Haemophagocytic lymphohistiocytosis † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Infections and infestations     
Pneumonia † 1  4/133 (3.01%)  4 1/67 (1.49%)  1
Appendicitis † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Influenza † 1  2/133 (1.50%)  2 0/67 (0.00%)  0
Abscess jaw † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Breast cellulitis † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Catheter site infection † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Device related infection † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Infectious pleural effusion † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Lower respiratory tract infection † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Respiratory tract infection † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Sepsis † 1  1/133 (0.75%)  1 2/67 (2.99%)  2
Soft tissue infection † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Urinary tract infection † 1  3/133 (2.26%)  3 2/67 (2.99%)  5
Injury, poisoning and procedural complications     
Hip fracture † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Lower limb fracture † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Subdural haemorrhage † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  3/133 (2.26%)  3 0/67 (0.00%)  0
Aspartate aminotransferase increased † 1  3/133 (2.26%)  3 0/67 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Decreased appetite † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteonecrosis of jaw † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Pain in extremity † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Pathological fracture † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Hepatic adenoma † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Uterine leiomyoma † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Nervous system disorders     
Seizure † 1  1/133 (0.75%)  1 1/67 (1.49%)  1
Brain oedema † 1  2/133 (1.50%)  2 0/67 (0.00%)  0
Cerebral haemorrhage † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Encephalopathy † 1  1/133 (0.75%)  1 1/67 (1.49%)  1
Neuropathy peripheral † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Psychiatric disorders     
Confusional state † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Panic attack † 1  0/133 (0.00%)  0 1/67 (1.49%)  1
Renal and urinary disorders     
IgA nephropathy † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis † 1  2/133 (1.50%)  2 1/67 (1.49%)  1
Asthma † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Pneumothorax † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Epistaxis † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Interstitial lung disease † 1  1/133 (0.75%)  1 0/67 (0.00%)  0
Pleural effusion † 1  1/133 (0.75%)  1 1/67 (1.49%)  1
1
Term from vocabulary, MedDRA v22.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Emtansine + Atezolizumab Trastuzumab Emtansine + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   130/133 (97.74%)      62/67 (92.54%)    
Blood and lymphatic system disorders     
Anaemia † 1  24/133 (18.05%)  30 6/67 (8.96%)  7
Neutropenia † 1  13/133 (9.77%)  21 4/67 (5.97%)  4
Thrombocytopenia † 1  42/133 (31.58%)  105 12/67 (17.91%)  22
Endocrine disorders     
Hypothyroidism † 1  18/133 (13.53%)  19 3/67 (4.48%)  3
Eye disorders     
Dry eye † 1  11/133 (8.27%)  12 4/67 (5.97%)  4
Lacrimation increased † 1  7/133 (5.26%)  9 1/67 (1.49%)  1
Vision blurred † 1  7/133 (5.26%)  8 1/67 (1.49%)  1
Gastrointestinal disorders     
Constipation † 1  29/133 (21.80%)  38 10/67 (14.93%)  15
Diarrhoea † 1  34/133 (25.56%)  50 15/67 (22.39%)  18
Dyspepsia † 1  14/133 (10.53%)  21 3/67 (4.48%)  3
Nausea † 1  51/133 (38.35%)  84 29/67 (43.28%)  37
Stomatitis † 1  13/133 (9.77%)  21 2/67 (2.99%)  2
Vomiting † 1  27/133 (20.30%)  36 15/67 (22.39%)  19
Abdominal pain † 1  17/133 (12.78%)  20 3/67 (4.48%)  3
Abdominal pain upper † 1  10/133 (7.52%)  10 3/67 (4.48%)  8
Dry mouth † 1  22/133 (16.54%)  23 9/67 (13.43%)  10
General disorders     
Asthenia † 1  23/133 (17.29%)  35 5/67 (7.46%)  6
Chills † 1  19/133 (14.29%)  27 6/67 (8.96%)  8
Fatigue † 1  53/133 (39.85%)  87 30/67 (44.78%)  43
Influenza like illness † 1  12/133 (9.02%)  16 8/67 (11.94%)  8
Mucosal inflammation † 1  16/133 (12.03%)  21 1/67 (1.49%)  1
Oedema peripheral † 1  7/133 (5.26%)  9 4/67 (5.97%)  4
Pyrexia † 1  44/133 (33.08%)  72 12/67 (17.91%)  18
Infections and infestations     
Nasopharyngitis † 1  15/133 (11.28%)  20 6/67 (8.96%)  8
Sinusitis † 1  7/133 (5.26%)  9 2/67 (2.99%)  2
Upper respiratory tract infection † 1  18/133 (13.53%)  28 9/67 (13.43%)  12
Urinary tract infection † 1  9/133 (6.77%)  10 8/67 (11.94%)  10
Injury, poisoning and procedural complications     
Fall † 1  10/133 (7.52%)  14 3/67 (4.48%)  9
Investigations     
Alanine aminotransferase increased † 1  31/133 (23.31%)  44 13/67 (19.40%)  18
Aspartate aminotransferase increased † 1  40/133 (30.08%)  56 14/67 (20.90%)  19
Blood alkaline phosphatase increased † 1  11/133 (8.27%)  12 6/67 (8.96%)  8
Gamma-glutamyltransferase increased † 1  7/133 (5.26%)  7 2/67 (2.99%)  2
Weight decreased † 1  13/133 (9.77%)  13 3/67 (4.48%)  3
Metabolism and nutrition disorders     
Decreased appetite † 1  30/133 (22.56%)  52 12/67 (17.91%)  14
Hypokalaemia † 1  13/133 (9.77%)  16 4/67 (5.97%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  26/133 (19.55%)  37 8/67 (11.94%)  9
Myalgia † 1  24/133 (18.05%)  26 10/67 (14.93%)  16
Back pain † 1  15/133 (11.28%)  19 8/67 (11.94%)  9
Bone pain † 1  8/133 (6.02%)  8 3/67 (4.48%)  8
Muscle spasms † 1  10/133 (7.52%)  13 7/67 (10.45%)  8
Musculoskeletal pain † 1  10/133 (7.52%)  12 6/67 (8.96%)  6
Pain in extremity † 1  9/133 (6.77%)  10 4/67 (5.97%)  5
Nervous system disorders     
Dizziness † 1  18/133 (13.53%)  18 9/67 (13.43%)  10
Dysgeusia † 1  6/133 (4.51%)  6 5/67 (7.46%)  6
Headache † 1  38/133 (28.57%)  62 17/67 (25.37%)  27
Paraesthesia † 1  9/133 (6.77%)  16 2/67 (2.99%)  2
Neuropathy peripheral † 1  18/133 (13.53%)  20 7/67 (10.45%)  8
Peripheral sensory neuropathy † 1  11/133 (8.27%)  11 5/67 (7.46%)  6
Polyneuropathy † 1  2/133 (1.50%)  2 4/67 (5.97%)  4
Psychiatric disorders     
Anxiety † 1  2/133 (1.50%)  2 6/67 (8.96%)  6
Insomnia † 1  14/133 (10.53%)  15 2/67 (2.99%)  2
Respiratory, thoracic and mediastinal disorders     
Cough † 1  25/133 (18.80%)  28 10/67 (14.93%)  12
Dyspnoea † 1  16/133 (12.03%)  19 5/67 (7.46%)  6
Epistaxis † 1  28/133 (21.05%)  39 10/67 (14.93%)  13
Oropharyngeal pain † 1  7/133 (5.26%)  8 1/67 (1.49%)  1
Skin and subcutaneous tissue disorders     
Pruritus † 1  23/133 (17.29%)  30 4/67 (5.97%)  5
Rash † 1  32/133 (24.06%)  42 6/67 (8.96%)  11
Dry skin † 1  11/133 (8.27%)  12 0/67 (0.00%)  0
Vascular disorders     
Hypertension † 1  4/133 (3.01%)  4 4/67 (5.97%)  4
1
Term from vocabulary, MedDRA v22.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02924883    
Other Study ID Numbers: WO30085
2015-004189-27 ( EudraCT Number )
First Submitted: September 21, 2016
First Posted: October 5, 2016
Results First Submitted: December 9, 2018
Results First Posted: February 12, 2019
Last Update Posted: February 17, 2021