Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

Triple Negative Breast Cancer, OptimICE-RD, AFT-65, NSABP B-63, Breast Neoplasms, Triple Negative Breast Neoplasms, Pembrolizumab, Capecitabine, Sacituzumab govitecan, Sacituzumab govitecan-hziy (SG), Sacituzumab govitecan-hziy (SG) + Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 and have recovered prior to starting study treatment.
  • Adequate organ function.

You CAN'T join if...

  • Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
  • 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 or concurrent treatment with any endocrine therapy agent.
  • Evidence of recurrent disease following preoperative therapy and surgery.
  • Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
  • Individuals with germline breast cancer gene (BRCA) mutations.
  • 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%
  • Active serious infections requiring anti-microbial therapy.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • Stockton Hematology Oncology Medical Group accepting new patients
    Stockton California 95204 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT05633654
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1514 study participants
Last Updated