Tests a drug combination after surgery for triple negative breast cancer

Trial details

Who runs it

Gilead Sciences

Trial code

NCT05633654EU 2024-512279-10-00

Record updated

4 November 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:; TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)); Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery; Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment; Adequate organ function.

Exclusion: Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer; Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor; Evidence of recurrent disease following preoperative therapy and surgery; Individuals with germline breast cancer gene (BRCA) mutations; Active serious infections requiring anti-microbial therapy; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment; Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%.

ClinicalTrials.gov NCT05633654 · EU CTIS 2024-512279-10-00