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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Sacituzumab govitecan-hziy (SG) (drug), Pembrolizumab (drug), Capecitabine (drug)
How long the study runs: Study runs about 104 months (dates as stated)
About the drug or intervention: Sacituzumab govitecan-hziy (SG) — drug: Administered intravenously · Pembrolizumab — drug: Administered intravenously · Capecitabine — drug: Tablets administered orally
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 1,514
Started: 2022-12-12
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for triple negative breast cancer
• Phase3 - 1,514 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with triple negative breast cancer

Where?

• Cottingham - Hull University Teaching Hospitals NHS Trust
• Edgbaston - University Hospitals Birmingham NHS Foundation Trust
• Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust
• London - Barts Health NHS Trust
• +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Triple Negative Breast Cancer

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

triple negativeERPRHER2CD137

Treatment history

Treatments you must have had:

✓ received appropriate radiotherapy aligned with local/institutional practice and have recovered

What the study is looking for

✓Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after...
✓Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and...
✓Submission of both pre-before surgery treatment diagnostic biopsy and resected residual invasive disease tissue.
✓activity scale (ECOG) performance status 0-1.
✓Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered...

Who cannot take part

✗Stage IV (that has spread) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
✗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.
✗Active serious infections requiring anti-microbial therapy.

See the full 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.