Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (ASCENT)

• ClinicalTrials.gov Identifier: NCT02574455
• Recruitment Status: Completed
• First Posted: October 12, 2015
• Results First Posted: April 30, 2021
• Last Update Posted: June 15, 2022
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer
• Interventions: Drug: Sacituzumab govitecan; Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine
• Enrollment: 529

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Belgium, Canada, France, Germany, Spain, the United Kingdom, and the United States. The first participant was screened on 07 November 2017. The last study visit occurred on 08 December 2020.
Pre-assignment Details	730 participants were screened.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Period Title: Overall Study
Started	267	262
Enrolled and Treated	258	224
Completed	0	0
Not Completed	267	262
Reason Not Completed
Death	197	210
Withdrawal of Consent	11	28
Lost to Follow-up	4	4
Sponsor's Decision	55	20

Baseline Characteristics

Arm/Group Title		Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)	Total
Arm/Group Description		Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.	Total of all reporting groups
Overall Number of Baseline Participants		267	262	529
Baseline Analysis Population Description		The Intent-to-Treat (ITT) Population included all randomized participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	267 participants	262 participants	529 participants
		54.0 (11.34)	54.0 (11.69)	54.0 (11.50)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	267 participants	262 participants	529 participants
	Female	265	262	527
	Male	2	0	2
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	267 participants	262 participants	529 participants
	Hispanic or Latino	20	25	45
	Not Hispanic or Latino	234	226	460
	Unknown or Not Reported	13	11	24
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	267 participants	262 participants	529 participants
	Asian	13	9	22
	Black	28	34	62
	White	215	203	418
	Other	11	16	27
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	267 participants	262 participants	529 participants
Belgium		20	25	45
Canada		3	2	5
France		33	29	62
Germany		0	2	2
Spain		32	26	58
United Kingdom		7	8	15
United States		172	170	342

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
Description	PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Time Frame	From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

The BM-ve Population included all randomized participants who were randomized to the strata of no baseline brain metastasis at the time of randomization.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	235	233
Median (95% Confidence Interval); Unit of Measure: months
	5.6; (4.3 to 6.3)	1.7; (1.5 to 2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.387
	Confidence Interval	(2-Sided) 95%; 0.305 to 0.492
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
Description	PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
Time Frame	From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

The ITT Population included all randomized participants.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	267	262
Median (95% Confidence Interval); Unit of Measure: months
	4.8; (4.1 to 5.8)	1.7; (1.5 to 2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.413
	Confidence Interval	(2-Sided) 95%; 0.330 to 0.517
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Overall Survival (OS) in BM-ve Population
Description	Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.
Time Frame	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	235	233
Median (95% Confidence Interval); Unit of Measure: months
	12.1; (10.7 to 14.0)	6.7; (5.8 to 7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.481
	Confidence Interval	(2-Sided) 95%; 0.390 to 0.592
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Overall Survival (OS) in ITT Population
Description	Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.
Time Frame	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

Outcome Measure Data

Analysis Population Description

Participants in the ITT Population were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	267	262
Median (95% Confidence Interval); Unit of Measure: months
	11.8; (10.5 to 13.8)	6.9; (5.9 to 7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.514
	Confidence Interval	(2-Sided) 95%; 0.422 to 0.625
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
Description	ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time Frame	From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population with available data were analyzed.

Arm/Group Title		Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:		Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed		235	233
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
ORR by IRC Assessment	Number Analyzed	230 participants	230 participants
		34.9; (28.8 to 41.4)	4.7; (2.4 to 8.3)
ORR by Investigator Assessment	Number Analyzed	235 participants	233 participants
		33.2; (27.2 to 39.6)	6.4; (3.6 to 10.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	ORR by IRC Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	10.859
	Confidence Interval	(2-Sided) 95%; 5.590 to 21.095
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	ORR by Investigator Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.363
	Confidence Interval	(2-Sided) 95%; 4.063 to 13.341
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Time to Objective Response by the Investigator Assessment in BM-ve Population
Description	Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time Frame	From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population with objective response were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	78	15
Mean (Standard Deviation); Unit of Measure: months
	2.14 (1.322)	2.72 (2.933)

7. Secondary Outcome

Title	Time to Objective Response by the IRC Assessment in BM-ve Population
Description	Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.
Time Frame	From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population with objective response were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	82	11
Mean (Standard Deviation); Unit of Measure: months
	2.67 (1.913)	1.86 (0.919)

8. Secondary Outcome

Title	Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
Description	DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.
Time Frame	From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population with objective response were analyzed.

Arm/Group Title		Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:		Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed		82	15
Median (95% Confidence Interval); Unit of Measure: months
IRC Assessment	Number Analyzed	82 participants	11 participants
		6.3; (5.5 to 7.9)	3.6 [1]; (2.8 to NA)
Investigator Assessment	Number Analyzed	78 participants	15 participants
		6.9; (5.6 to 7.9)	3.0; (2.8 to 4.3)

[1]

Due to smaller number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	DOR by IRC Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0683
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.407
	Confidence Interval	(2-Sided) 95%; 0.150 to 1.107
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	DOR by Investigator Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.212
	Confidence Interval	(2-Sided) 95%; 0.103 to 0.435
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Time to Progression (TTP) by Investigator Assessment in BM-ve Population
Description	Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.
Time Frame	From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	235	233
Median (95% Confidence Interval); Unit of Measure: months
	5.7; (5.2 to 6.9)	1.8; (1.5 to 2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	TTP by Investigator Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.317
	Confidence Interval	(2-Sided) 95%; 0.248 to 0.404
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Time to Progression (TTP) by IRC Assessment in BM-ve Population
Description	Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.
Time Frame	From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	235	233
Median (95% Confidence Interval); Unit of Measure: months
	5.8; (4.8 to 6.9)	2.1; (1.5 to 2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	TTP by IRC Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.406
	Confidence Interval	(2-Sided) 95%; 0.315 to 0.525
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
Description	CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the BM-ve Population were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	235	233
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
IRC Assessment	44.7; (38.2 to 51.3)	8.6; (5.3 to 12.9)
Investigator Assessment	45.5; (39.0 to 52.1)	10.3; (6.7 to 14.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	CBR by IRC Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.543
	Confidence Interval	(2-Sided) 95%; 5.055 to 14.437
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sacituzumab Govitecan, Treatment of Physician's Choice (TPC)
	Comments	CBR by Investigator Assessment
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.492
	Confidence Interval	(2-Sided) 95%; 4.540 to 12.364
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
Description	Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: Fatal; Life-threatening; Disabling/incapacitating; Results in hospitalization or prolongs a hospital stay; A congenital abnormality; Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above
Time Frame	First dose date up to last follow-up (maximum up to 30.8 months)

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	258	224
Measure Type: Number; Unit of Measure: percentage of participants
Any TEAEs	99.6	97.8
SAEs	26.7	28.6
TEAEs Leading to Discontinuation of Study Drug	4.7	5.4

13. Secondary Outcome

Title	Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Description	The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement.
Time Frame	Baseline; End of Treatment (EOT) (up to 29.6 months)

Outcome Measure Data

Analysis Population Description

Participants in the Safety analysis set with available data were analyzed.

Arm/Group Title		Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:		Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed		258	224
Mean (Standard Deviation); Unit of Measure: score on a scale
Global Health Status/QoL: Baseline	Number Analyzed	247 participants	217 participants
		61.9 (21.31)	56.4 (22.21)
Global Health Status/QoL: Change From Baseline at EOT	Number Analyzed	181 participants	147 participants
		-5.8 (22.71)	-9.4 (20.46)
Physical Functioning: Baseline	Number Analyzed	248 participants	217 participants
		73.2 (21.69)	71.2 (21.24)
Physical Functioning: Change From Baseline at EOT	Number Analyzed	183 participants	147 participants
		-4.6 (21.07)	-13.5 (20.54)
Role Functioning: Baseline	Number Analyzed	248 participants	217 participants
		68.1 (30.35)	65.1 (30.31)
Role Functioning: Change From Baseline at EOT	Number Analyzed	183 participants	146 participants
		-8.4 (32.87)	-18.8 (29.83)
Emotional Functioning: Baseline	Number Analyzed	247 participants	217 participants
		71.9 (22.33)	68.9 (23.87)
Emotional Functioning: Change From Baseline at EOT	Number Analyzed	182 participants	147 participants
		-3.8 (25.02)	-3.5 (22.16)
Cognitive Functioning: Baseline	Number Analyzed	247 participants	217 participants
		81.7 (21.08)	79.5 (23.91)
Cognitive Functioning: Change From Baseline at EOT	Number Analyzed	182 participants	147 participants
		-7.5 (22.81)	-6.1 (22.92)
Social Functioning: Baseline	Number Analyzed	247 participants	216 participants
		69.1 (29.96)	69.6 (26.88)
Social Functioning: Change From Baseline at EOT	Number Analyzed	182 participants	145 participants
		-5.9 (27.52)	-10.3 (29.60)
Fatigue: Baseline	Number Analyzed	248 participants	217 participants
		39.4 (25.72)	42.1 (25.99)
Fatigue: Change From Baseline at EOT	Number Analyzed	183 participants	147 participants
		5.1 (25.93)	14.0 (23.05)
Nausea and Vomiting: Baseline	Number Analyzed	248 participants	217 participants
		8.3 (16.36)	10.3 (18.26)
Nausea and Vomiting: Change From Baseline at EOT	Number Analyzed	183 participants	147 participants
		5.2 (23.93)	7.3 (23.33)
Pain: Baseline	Number Analyzed	248 participants	217 participants
		37.9 (30.54)	42.5 (30.38)
Pain: Change From Baseline at EOT	Number Analyzed	183 participants	147 participants
		2.8 (27.84)	6.8 (30.33)
Dyspnoea: Baseline	Number Analyzed	248 participants	217 participants
		25.4 (30.36)	25.0 (29.09)
Dyspnoea: Change From Baseline at EOT	Number Analyzed	180 participants	146 participants
		0.7 (30.91)	5.9 (28.95)
Insomnia: Baseline	Number Analyzed	248 participants	217 participants
		33.2 (30.95)	35.6 (31.42)
Insomnia: Change From Baseline at EOT	Number Analyzed	183 participants	147 participants
		4.4 (34.67)	-4.3 (32.24)
Appetite Loss: Baseline	Number Analyzed	248 participants	217 participants
		20.8 (27.34)	25.8 (28.68)
Appetite Loss: Change From Baseline at EOT	Number Analyzed	183 participants	147 participants
		3.1 (31.78)	10.0 (30.32)
Constipation: Baseline	Number Analyzed	247 participants	217 participants
		17.7 (27.18)	19.0 (26.56)
Constipation: Change From Baseline at EOT	Number Analyzed	182 participants	147 participants
		3.3 (28.92)	7.0 (31.27)
Diarrhoea: Baseline	Number Analyzed	247 participants	217 participants
		7.2 (17.73)	6.5 (15.69)
Diarrhoea: Change From Baseline at EOT	Number Analyzed	182 participants	147 participants
		11.4 (28.56)	3.6 (22.46)
Financial Difficulties: Baseline	Number Analyzed	246 participants	217 participants
		27.6 (34.39)	22.4 (30.91)
Financial Difficulties: Change From Baseline at EOT	Number Analyzed	181 participants	147 participants
		0.4 (24.09)	1.1 (23.54)

14. Secondary Outcome

Title	Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
Description	Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.
Time Frame	First dose date up to last follow-up (maximum up to 30.8 months)

Outcome Measure Data

Analysis Population Description

Participants in the Safety analysis set were analyzed.

Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description:	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
Overall Number of Participants Analyzed	258	224
Measure Type: Number; Unit of Measure: percentage of participants
Anemia	8.9	5.4
Lymphocyte Count Decreased	33.3	25.0
Neutrophil Count Decreased	48.8	35.3
Platelet Count Decreased	1.2	2.7
White Blood Cell Decreased	41.1	25.4
Alanine Aminotransferase Increased	1.2	2.2
Alkaline Phosphatase Increased	3.1	3.6
Aspartate Aminotransferase Increased	3.5	2.2
Blood Bilirubin Increased	1.9	2.7
Creatinine Increased	0.4	0
Hypercalcemia	0	0.4
Hyperglycemia	3.1	3.1
Hyperkalemia	0.8	0
Hypermagnesemia	0.4	0.4
Hypernatremia	0	0
Hypoalbumenemia	0.8	1.3
Hypocalcemia	1.6	1.3
Hypoglycemia	0.4	0
Hypokalemia	4.3	0.9
Hypomagnesemia	0.8	0
Hyponatremia	3.9	3.6
Hypophosphatemia	8.1	3.6

Adverse Events

Time Frame	Adverse Events: First dose date up to last follow-up (maximum up to 30.8 months); All-Cause Mortality: From randomization up to 30.8 months
Adverse Event Reporting Description	Serious Adverse Events and Other Adverse Events: Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC. All-Cause Mortality: The ITT Population included all randomized participants.
Arm/Group Title	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
Arm/Group Description	Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.	Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
All-Cause Mortality
	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	201/267 (75.28%)	222/262 (84.73%)
Serious Adverse Events
	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	69/258 (26.74%)	64/224 (28.57%)
Blood and lymphatic system disorders
Anaemia † 1	3/258 (1.16%)	2/224 (0.89%)
Febrile neutropenia † 1	13/258 (5.04%)	4/224 (1.79%)
Neutropenia † 1	5/258 (1.94%)	1/224 (0.45%)
Thrombocytopenia † 1	1/258 (0.39%)	0/224 (0.00%)
Cardiac disorders
Atrial fibrillation † 1	0/258 (0.00%)	1/224 (0.45%)
Mitral valve incompetence † 1	1/258 (0.39%)	0/224 (0.00%)
Pericardial effusion † 1	0/258 (0.00%)	2/224 (0.89%)
Sinus tachycardia † 1	0/258 (0.00%)	1/224 (0.45%)
Gastrointestinal disorders
Abdominal pain † 1	3/258 (1.16%)	3/224 (1.34%)
Abdominal pain upper † 1	1/258 (0.39%)	0/224 (0.00%)
Colitis † 1	1/258 (0.39%)	0/224 (0.00%)
Constipation † 1	0/258 (0.00%)	1/224 (0.45%)
Diarrhoea † 1	9/258 (3.49%)	0/224 (0.00%)
Dyspepsia † 1	0/258 (0.00%)	1/224 (0.45%)
Enteritis † 1	1/258 (0.39%)	0/224 (0.00%)
Nausea † 1	2/258 (0.78%)	0/224 (0.00%)
Neutropenic colitis † 1	1/258 (0.39%)	0/224 (0.00%)
Oesophageal varices haemorrhage † 1	1/258 (0.39%)	0/224 (0.00%)
Pancreatitis acute † 1	1/258 (0.39%)	1/224 (0.45%)
Vomiting † 1	2/258 (0.78%)	0/224 (0.00%)
General disorders
Asthenia † 1	1/258 (0.39%)	1/224 (0.45%)
Chest pain † 1	0/258 (0.00%)	1/224 (0.45%)
General physical health deterioration † 1	0/258 (0.00%)	1/224 (0.45%)
Hyperthermia † 1	0/258 (0.00%)	1/224 (0.45%)
Incarcerated hernia † 1	1/258 (0.39%)	0/224 (0.00%)
Infusion site extravasation † 1	1/258 (0.39%)	0/224 (0.00%)
Non-cardiac chest pain † 1	1/258 (0.39%)	0/224 (0.00%)
Pain † 1	1/258 (0.39%)	0/224 (0.00%)
Pyrexia † 1	3/258 (1.16%)	5/224 (2.23%)
Swelling † 1	0/258 (0.00%)	1/224 (0.45%)
Hepatobiliary disorders
Hyperbilirubinaemia † 1	1/258 (0.39%)	1/224 (0.45%)
Portal vein thrombosis † 1	1/258 (0.39%)	0/224 (0.00%)
Infections and infestations
Bronchitis † 1	1/258 (0.39%)	0/224 (0.00%)
Candida infection † 1	0/258 (0.00%)	1/224 (0.45%)
Cellulitis † 1	3/258 (1.16%)	2/224 (0.89%)
Corynebacterium infection † 1	0/258 (0.00%)	1/224 (0.45%)
Device related infection † 1	3/258 (1.16%)	0/224 (0.00%)
Diverticulitis † 1	1/258 (0.39%)	0/224 (0.00%)
Empyema † 1	1/258 (0.39%)	0/224 (0.00%)
Herpes zoster † 1	1/258 (0.39%)	0/224 (0.00%)
Lower respiratory tract infection † 1	1/258 (0.39%)	1/224 (0.45%)
Lung abscess † 1	1/258 (0.39%)	0/224 (0.00%)
Neutropenic sepsis † 1	0/258 (0.00%)	1/224 (0.45%)
Phlebitis infective † 1	1/258 (0.39%)	0/224 (0.00%)
Pneumonia † 1	7/258 (2.71%)	4/224 (1.79%)
Respiratory tract infection † 1	1/258 (0.39%)	0/224 (0.00%)
Sepsis † 1	2/258 (0.78%)	4/224 (1.79%)
Streptococcal bacteraemia † 1	0/258 (0.00%)	1/224 (0.45%)
Urinary tract infection † 1	2/258 (0.78%)	1/224 (0.45%)
Wound infection † 1	1/258 (0.39%)	1/224 (0.45%)
Injury, poisoning and procedural complications
Humerus fracture † 1	1/258 (0.39%)	0/224 (0.00%)
Radiation necrosis † 1	0/258 (0.00%)	1/224 (0.45%)
Investigations
Blood lactic acid increased † 1	0/258 (0.00%)	1/224 (0.45%)
Neutrophil count decreased † 1	2/258 (0.78%)	1/224 (0.45%)
Platelet count decreased † 1	1/258 (0.39%)	0/224 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	1/258 (0.39%)	0/224 (0.00%)
Hypokalaemia † 1	0/258 (0.00%)	1/224 (0.45%)
Musculoskeletal and connective tissue disorders
Back pain † 1	2/258 (0.78%)	4/224 (1.79%)
Musculoskeletal chest pain † 1	0/258 (0.00%)	1/224 (0.45%)
Pain in extremity † 1	1/258 (0.39%)	0/224 (0.00%)
Tendonitis † 1	1/258 (0.39%)	0/224 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage † 1	1/258 (0.39%)	0/224 (0.00%)
Nervous system disorders
Encephalopathy † 1	0/258 (0.00%)	1/224 (0.45%)
Facial paralysis † 1	0/258 (0.00%)	1/224 (0.45%)
Headache † 1	2/258 (0.78%)	0/224 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous † 1	1/258 (0.39%)	0/224 (0.00%)
Pregnancy † 1	1/258 (0.39%)	0/224 (0.00%)
Psychiatric disorders
Mental status changes † 1	0/258 (0.00%)	1/224 (0.45%)
Reproductive system and breast disorders
Breast ulceration † 1	0/258 (0.00%)	1/224 (0.45%)
Vaginal haemorrhage † 1	1/258 (0.39%)	0/224 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	0/258 (0.00%)	1/224 (0.45%)
Dyspnoea † 1	2/258 (0.78%)	7/224 (3.13%)
Hypoxia † 1	2/258 (0.78%)	1/224 (0.45%)
Pleural effusion † 1	2/258 (0.78%)	6/224 (2.68%)
Pneumonitis † 1	1/258 (0.39%)	0/224 (0.00%)
Pneumothorax † 1	1/258 (0.39%)	1/224 (0.45%)
Pulmonary embolism † 1	3/258 (1.16%)	2/224 (0.89%)
Respiratory distress † 1	0/258 (0.00%)	1/224 (0.45%)
Respiratory failure † 1	2/258 (0.78%)	2/224 (0.89%)
Skin and subcutaneous tissue disorders
Rash maculo-papular † 1	1/258 (0.39%)	0/224 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	2/258 (0.78%)	1/224 (0.45%)
Hypotension † 1	0/258 (0.00%)	1/224 (0.45%)
Lymphoedema † 1	0/258 (0.00%)	1/224 (0.45%)
1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Sacituzumab Govitecan	Treatment of Physician's Choice (TPC)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	256/258 (99.22%)	213/224 (95.09%)
Blood and lymphatic system disorders
Anaemia † 1	102/258 (39.53%)	61/224 (27.23%)
Neutropenia † 1	108/258 (41.86%)	56/224 (25.00%)
Thrombocytopenia † 1	9/258 (3.49%)	14/224 (6.25%)
Gastrointestinal disorders
Abdominal pain † 1	54/258 (20.93%)	16/224 (7.14%)
Abdominal pain upper † 1	23/258 (8.91%)	8/224 (3.57%)
Constipation † 1	96/258 (37.21%)	52/224 (23.21%)
Diarrhoea † 1	168/258 (65.12%)	38/224 (16.96%)
Gastrooesophageal reflux disease † 1	14/258 (5.43%)	7/224 (3.13%)
Nausea † 1	160/258 (62.02%)	68/224 (30.36%)
Stomatitis † 1	27/258 (10.47%)	14/224 (6.25%)
Vomiting † 1	85/258 (32.95%)	36/224 (16.07%)
General disorders
Asthenia † 1	39/258 (15.12%)	28/224 (12.50%)
Chills † 1	14/258 (5.43%)	6/224 (2.68%)
Fatigue † 1	133/258 (51.55%)	89/224 (39.73%)
Mucosal inflammation † 1	20/258 (7.75%)	14/224 (6.25%)
Oedema peripheral † 1	25/258 (9.69%)	24/224 (10.71%)
Pain † 1	18/258 (6.98%)	11/224 (4.91%)
Pyrexia † 1	37/258 (14.34%)	27/224 (12.05%)
Infections and infestations
Nasopharyngitis † 1	18/258 (6.98%)	5/224 (2.23%)
Upper respiratory tract infection † 1	32/258 (12.40%)	7/224 (3.13%)
Urinary tract infection † 1	35/258 (13.57%)	17/224 (7.59%)
Investigations
Alanine aminotransferase increased † 1	28/258 (10.85%)	22/224 (9.82%)
Aspartate aminotransferase increased † 1	30/258 (11.63%)	27/224 (12.05%)
Blood alkaline phosphatase increased † 1	17/258 (6.59%)	12/224 (5.36%)
Lymphocyte count decreased † 1	20/258 (7.75%)	13/224 (5.80%)
Neutrophil count decreased † 1	71/258 (27.52%)	45/224 (20.09%)
Platelet count decreased † 1	7/258 (2.71%)	15/224 (6.70%)
Weight decreased † 1	22/258 (8.53%)	15/224 (6.70%)
White blood cell count decreased † 1	33/258 (12.79%)	23/224 (10.27%)
Metabolism and nutrition disorders
Decreased appetite † 1	71/258 (27.52%)	46/224 (20.54%)
Hyperglycaemia † 1	18/258 (6.98%)	12/224 (5.36%)
Hypocalcaemia † 1	17/258 (6.59%)	5/224 (2.23%)
Hypokalaemia † 1	46/258 (17.83%)	29/224 (12.95%)
Hypomagnesaemia † 1	32/258 (12.40%)	13/224 (5.80%)
Hypophosphataemia † 1	15/258 (5.81%)	9/224 (4.02%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	33/258 (12.79%)	16/224 (7.14%)
Back pain † 1	44/258 (17.05%)	30/224 (13.39%)
Bone pain † 1	21/258 (8.14%)	14/224 (6.25%)
Musculoskeletal chest pain † 1	17/258 (6.59%)	6/224 (2.68%)
Myalgia † 1	12/258 (4.65%)	19/224 (8.48%)
Pain in extremity † 1	21/258 (8.14%)	17/224 (7.59%)
Nervous system disorders
Dizziness † 1	28/258 (10.85%)	16/224 (7.14%)
Dysgeusia † 1	22/258 (8.53%)	6/224 (2.68%)
Headache † 1	47/258 (18.22%)	28/224 (12.50%)
Neuropathy peripheral † 1	9/258 (3.49%)	24/224 (10.71%)
Psychiatric disorders
Anxiety † 1	17/258 (6.59%)	8/224 (3.57%)
Insomnia † 1	30/258 (11.63%)	11/224 (4.91%)
Reproductive system and breast disorders
Breast pain † 1	14/258 (5.43%)	8/224 (3.57%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	61/258 (23.64%)	40/224 (17.86%)
Dyspnoea † 1	45/258 (17.44%)	41/224 (18.30%)
Dyspnoea exertional † 1	13/258 (5.04%)	3/224 (1.34%)
Epistaxis † 1	13/258 (5.04%)	1/224 (0.45%)
Nasal congestion † 1	13/258 (5.04%)	3/224 (1.34%)
Oropharyngeal pain † 1	14/258 (5.43%)	9/224 (4.02%)
Rhinorrhoea † 1	15/258 (5.81%)	1/224 (0.45%)
Skin and subcutaneous tissue disorders
Alopecia † 1	121/258 (46.90%)	36/224 (16.07%)
Dry skin † 1	17/258 (6.59%)	3/224 (1.34%)
Pruritus † 1	26/258 (10.08%)	7/224 (3.13%)
Rash † 1	32/258 (12.40%)	12/224 (5.36%)
Rash maculo-papular † 1	18/258 (6.98%)	3/224 (1.34%)
Vascular disorders
Hypertension † 1	17/258 (6.59%)	14/224 (6.25%)
Lymphoedema † 1	14/258 (5.43%)	7/224 (3.13%)
1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

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.

After study conclusion and without prior written approval from Immunomedics and Gilead sciences, investigators in this study may communicate, orally present/publish in scientific journals/other media only after following conditions have been met:

• The results of the study in their entirety have been publicly disclosed by or with the consent of Immunomedics and Gilead sciences in an abstract, manuscript/presentation form; or
• The study has been completed at all study sites for at least 2 years

Results Point of Contact

• Name/Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences
• Phone: 1-833-445-3230 (GILEAD-0)
• EMail: GileadClinicalTrials@gilead.com

Publications of Results:

Huvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05

Other Publications:

Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.

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

O'Shaughnessy J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu Y, Phan S, Cortes J. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11.

Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1.

Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.

McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.

Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT02574455
• Other Study ID Numbers: IMMU-132-05; 2017-003019-21 ( EudraCT Number )
• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Results First Submitted: March 11, 2021
• Results First Posted: April 30, 2021
• Last Update Posted: June 15, 2022