A Phase 3 interventional study of Sacituzumab Govitecan-hziy and Pembrolizumab in Triple Negative Breast Cancer and PD-L1 Positive, sponsored by Gilead Sciences. Active, not recruiting at 504 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.
This study's enrollment of 443 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative 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 with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
Drug: Sacituzumab Govitecan-hziy · Drug: Pembrolizumab
Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of 28-day cycles * nab-Paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of 28-day cycles * Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
Drug: Pembrolizumab · Drug: Paclitaxel · Drug: nab-Paclitaxel · Drug: Gemcitabine · Drug: Carboplatin
Administered intravenously
Also known as: IMMU-132, Trodelvy™, GS-0132
Administered intravenously
Also known as: KEYTRUDA®
Administered intravenously
Also known as: Taxol®
Administered intravenously
Also known as: Abraxane®
Administered intravenously
Also known as: Gemzar
Administered intravenously
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
Time frame: Randomization up to approximately 33 months
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Time frame: Randomization up to approximately 53 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time frame: Randomization up to approximately 53 months
Duration of Response (DOR) as Assessed by BICR 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: Randomization up to approximately 53 months
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
Time frame: Randomization up to approximately 53 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose date up to 53 months plus 30 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 53 months plus 30 days
Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. 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 denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
Time frame: Randomization up to approximately 53 months
TTD of Pain Score as Measured by EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. 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 denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
Time frame: Randomization up to approximately 53 months
TTD of Fatigue Score as Measured by EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. 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 denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
Time frame: Randomization up to approximately 53 months
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. 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 denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
Time frame: Randomization up to approximately 53 months
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. 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 denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
Time frame: Randomization up to approximately 53 months
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