UPCC 15123 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

Post-Surgery Treatment Study for Triple Negative Breast Cancer

Enrolling By Invitation
18 years or above
All
Phase 3
1514 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Triple Negative Breast Cancer
  • Age: 18 years or above
  • Gender: All

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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 endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
  • 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.

This study investigates the effectiveness and safety of an investigational medication combined with pembrolizumab compared to a treatment of the physician's choice in patients with triple negative breast cancer. The purpose is to evaluate these treatments in patients who still have invasive disease after surgery and pre-surgical therapy.

Participants will receive either the investigational medication with pembrolizumab or a treatment chosen by their physician, which could include pembrolizumab alone or with capecitabine. The study will involve regular monitoring and assessments to observe the effects of the treatments on the residual cancer.

  • Who can participate: Adults over 18 with residual invasive triple negative breast cancer after surgery and pre-surgical treatment are eligible. Participants must have adequate organ function and have undergone appropriate radiotherapy. Key exclusions include those with metastatic breast cancer or a history of invasive breast cancer.
  • Study details: Participants will be randomly assigned to receive either the investigational medication with pembrolizumab or a physician's choice treatment. They will undergo regular health assessments and provide tissue samples for study analysis.
Updated on 15 Jul 2026. Study ID: 23-1319
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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