A Phase 3 interventional study of Sacituzumab Govitecan-hziy and Paclitaxel in Locally Advanced or Unresectable Metastatic Breast Cancer and Stage IV Breast Cancer, sponsored by Gilead Sciences. Active, not recruiting at 288 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 654 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Individuals must have at least one of the following:
Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.
Key Exclusion Criteria:
Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
Drug: Sacituzumab Govitecan-hziy
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: * paclitaxel 80 mg/m\^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * nab-Paclitaxel 100 mg/m\^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * capecitabine at 1000-1250 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
Drug: Paclitaxel · Drug: Nab-paclitaxel · Drug: Capecitabine
Administered intravenously
Also known as: Trodelvy™, GS-0132, IMMU-132
Administered intravenously
Also known as: Taxol®
Administered intravenously
Also known as: Abraxane®
Administered orally
Also known as: Xeloda®
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.
Time frame: Up to approximately 29 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Time frame: Until death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time frame: Until progression, up to approximately 60 months
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.
Time frame: Baseline, Week 16
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Time frame: Up to approximately 60 months
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Time frame: Until progression or death, up to approximately 60 months
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time frame: Up to approximately 60 months
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).
Time frame: Until progression or death, up to approximately 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: First dose date up to 30 days post last dose, up to approximately 60 months
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
Time frame: First dose date up to 30 days post last dose, up to approximately 60 months
Showing the first 100 of 288 sites across 28 countries.
Plan to share: No
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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