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Study of Sacituzumab Govitecan-hziy and Pembrolizumab for Triple Negative Breast Cancer

This study is investigating if a combination of sacituzumab govitecan-hziy and pembrolizumab is effective and safe for people with triple negative breast cancer (TNBC) that remains after surgery and initial treatments. You may be able to join if you are over 18 and have TNBC that still has invasive cells after surgery and neoadjuvant therapy (treatment before surgery). The study will compare this drug combination to standard treatments chosen by your doctor, which could include pembrolizumab alone or with capecitabine. Researchers will measure how long people live without the cancer returning (Invasive Disease-free Survival) for up to 60 months to see if the new treatment is successful. The current status of this study is unclear, and it plans to enroll 1514 participants.

Study design
This is an interventional study comparing different drug treatments. It plans to enroll 1514 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months to measure Invasive Disease-free Survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05633654

Study of Sacituzumab Govitecan-hziy 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 (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Gilead Sciences
~1,514 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Sacituzumab govitecan-hziy (SG)PembrolizumabCapecitabine

At a glance

Recruiting sites
271 of 356 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Invasive Disease-free Survival (iDFS)
Measured over Up to 60 months

Conditions

Triple Negative Breast Cancer

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Where it's being run

356 sites across 55 states
Germany51
Spain37
Florida15
Brazil15
California14
France14
Italy13
New York12

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Eligibility criteria

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 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.

What this trial measures

  • Invasive Disease-free Survival (iDFS)Up to 60 months

    iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.