University of Texas MD Anderson Cancer Center, Houston, TX
PD-L1 Positive+3 More
Pembrolizumab - Drug
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What conditions do you have?
What conditions do you have?
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).
Breast Cancer (Triple Negative Breast Cancer (TNBC))
1 Primary · 11 Secondary · Reporting Duration: Randomization up to approximately 53 months
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Overall Survival (OS)
TTD of Fatigue Score as Measured by EORTC QLQ-C30
TTD of Pain Score as Measured by EORTC QLQ-C30
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
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)
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Pembrolizumab + Treatment of Physician's Choice (TPC)
1 of 2
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
1 of 2
440 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3
Sacituzumab Govitecan-hziy (SG) + PembrolizumabExperimental Group · 2 Interventions: Sacituzumab Govitecan-hziy, Pembrolizumab · Intervention Types: Drug, Drug
Pembrolizumab + Treatment of Physician's Choice (TPC)ActiveComparator Group · 5 Interventions: nab-Paclitaxel, Pembrolizumab, Gemcitabine, Paclitaxel, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug, Drug
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Screening: ~3 weeks
Reporting: randomization up to approximately 53 months
Closest Location: University of Texas MD Anderson Cancer Center · Houston, TX
2020First Recorded Clinical Trial
1 TrialsResearching PD-L1 Positive
732 CompletedClinical Trials
Who is running the clinical trial?
Gilead SciencesLead Sponsor
999 Previous Clinical Trials
657,064 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,626 Previous Clinical Trials
4,947,988 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
314 Previous Clinical Trials
176,222 Total Patients Enrolled
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:
You are of childbearing potential and you engage in heterosexual intercourse
You are on ART and have a well-controlled HIV infection/disease.
You have locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) and you have not received previous systemic therapy for advanced disease
You are eligible for this study if you have TNBC and have not received prior chemotherapy for metastatic disease.
You have measurable disease by CT or MRI as per RECIST criteria as evaluated locally.
Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
TNBC status and tumor PD-L1 CPS will be confirmed centrally on a recent or archival tumor specimen.
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.