RecruitingPhase 2NCT04468061

Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)


Sponsor

Dana-Farber Cancer Institute

Enrollment

110 participants

Start Date

Jul 20, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding pembrolizumab (an immunotherapy drug) to sacituzumab govitecan (a targeted chemotherapy) improves outcomes in patients with metastatic triple-negative breast cancer (TNBC) — an aggressive form of breast cancer that does not respond to hormone-based treatments. Participants must have low or no PD-L1 expression (a marker on cancer cells). **You may be eligible if:** - You have triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) that has spread or cannot be surgically removed - Your cancer has low or no PD-L1 expression - You have not yet received any treatment for metastatic disease (treatment-naive in the metastatic setting) - You have at least one measurable tumor (including bone-only disease) - You are willing to undergo tumor biopsies **You may NOT be eligible if:** - You have already received treatment for your metastatic disease - You have an active autoimmune disease requiring treatment - You are pregnant or breastfeeding - You have active, untreated brain metastases - You have significant heart, liver, or kidney dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan

Intravenous Infusion

DRUGPembrolizumab

Intravenous Infusion


Locations(15)

Stamford Hospital

Stamford, Connecticut, United States

Miami Cancer Institute at Baptist Health (Kendall)

Miami, Florida, United States

Miami Cancer Institute at Baptist Health

Plantation, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Eastern Maine Medical Center

Brewer, Maine, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

DFCI @ Foxborough

Foxborough, Massachusetts, United States

DFCI @ Milford Regional Hospital

Milford, Massachusetts, United States

DF/BWCC in Clinical Affiliation with South Shore Hospital

South Weymouth, Massachusetts, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Pennsylvania-Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sarah Cannon Research Institute

Chattanooga, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04468061


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