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Combination treatment for triple negative breast cancer after surgery

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

Phase 3 Interventional Gilead Sciences · NCT05633654

This study is testing if a new combination of two cancer drugs can help adults with triple negative breast cancer who still have cancer after surgery feel better and live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1514 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Drugs / interventionssacituzumab, pembrolizumab
Locations339 sites (Birmingham, Alabama and 338 other locations)
Trial IDNCT05633654 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of sacituzumab govitecan-hziy combined with pembrolizumab compared to the treatment of physician's choice in patients with triple negative breast cancer who have residual invasive disease following surgery and neoadjuvant therapy. Participants must be over 18 years old and have undergone adequate surgical removal of their cancer. The study aims to determine if this new combination therapy can improve outcomes for patients who still have cancer after standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with residual invasive triple negative breast cancer after neoadjuvant therapy and surgery.

Not a fit: Patients who have not undergone adequate surgical removal of their cancer or have other types of breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with residual triple negative breast cancer after surgery.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating triple negative breast cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 338 other locations

+289 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast CancerAFT-65GBG 119NSABP B-63OptimICE-RD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.