Title: A phase II study of neoadjuvant sacituzumab govitecan and pembrolizumab therapy for immunochemotherapy-resistant early-stage triple-negative breast cancer (TNBC)
Principal Investigator: Clinton Yam, MD, of MD Anderson Cancer Center in Houston
Description: Researchers are conducting a phase 2 study to evaluate neoadjuvant sacituzumab govitecan and pembrolizumab in patients with early-stage triple-negative breast cancer (TNBC) that has not responded well to other treatments.
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Patients will receive sacituzumab govitecan on days 1 and 8 of cycles 1-4, and pembrolizumab on days 1, 8, and 15 of each cycle.
The study’s primary objective is to determine the efficacy of the combination on pathologic complete response/residual cancer burden. Secondary objectives include determining safety, the objective response rate, distant recurrence-free survival, event-free survival, and overall survival.
To be eligible for this study, patients must be 18 years of age or older. They must have histologically or cytologically confirmed early-stage TNBC. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by MD Anderson Cancer Center in collaboration with Gilead Sciences.
Reference
ClinicalTrials.gov. A phase II study of neoadjuvant sacituzumab govitecan and pembrolizumab therapy for immunochemotherapy-resistant early-stage triple-negative breast cancer (TNBC). NCT05675579. Accessed May 30, 2023.
