A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Primary Objective

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

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Description

You are being asked to be in this research study because you have high-risk early triplenegative breast cancer (TNBC) without mutations in the BRCA1 or BRCA2 gene. For this study high-risk early TNBC is defined as any presence of TNBC that still remains in the breast or lymph node tissue after receiving treatment and undergoing surgery. This study plans to learn more about if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in patients with high-risk early TNBC when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Highlands Ranch Hospital
Lone Tree Medical Center
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Marie Wood

Marie Wood

Study ID

Protocol Number: 23-1465

More information available at ClinicalTrials.gov: NCT05633654

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