Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 14 of 14

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population	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)	The BM-ve Population included all randomized participants who were randomized to the strata of no baseline brain metastasis at the time of randomization.	months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) by IRC Assessment in the ITT Population	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)	The ITT Population included all randomized participants.	months	MEDIAN
SECONDARY	Overall Survival (OS) in BM-ve Population	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)	Participants in the BM-ve Population were analyzed.	months	MEDIAN
SECONDARY	Overall Survival (OS) in ITT Population	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)	Participants in the ITT Population were analyzed.	months	MEDIAN
SECONDARY	Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population	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)	Participants in the BM-ve Population with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Time to Objective Response by the Investigator Assessment in BM-ve Population	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)	Participants in the BM-ve Population with objective response were analyzed.	months	MEAN
SECONDARY	Time to Objective Response by the IRC Assessment in BM-ve Population	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)	Participants in the BM-ve Population with objective response were analyzed.	months	MEAN
SECONDARY	Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population	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)	Participants in the BM-ve Population with objective response were analyzed.	months	MEDIAN
SECONDARY	Time to Progression (TTP) by Investigator Assessment in BM-ve Population	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)	Participants in the BM-ve Population were analyzed.	months	MEDIAN
SECONDARY	Time to Progression (TTP) by IRC Assessment in BM-ve Population	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)	Participants in the BM-ve Population were analyzed.	months	MEDIAN
SECONDARY	Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population	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)	Participants in the BM-ve Population were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug	First dose date up to last follow-up (maximum up to 30.8 months)	Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score	Baseline; End of Treatment (EOT) (up to 29.6 months)	Participants in the Safety analysis set with available data were analyzed.	score on a scale	MEAN
SECONDARY	Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline	First dose date up to last follow-up (maximum up to 30.8 months)	Participants in the Safety analysis set were analyzed.	percentage of participants	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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