OncoMatch/Clinical Trials/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)
Is NCT05633654 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Sacituzumab govitecan-hziy (SG) and Pembrolizumab for triple negative breast cancer.
Treatment: Sacituzumab govitecan-hziy (SG) · Pembrolizumab · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (≤10%)
estrogen receptor (ER) ≤ 10%
Required: PR (PGR) expression (≤10%)
progesterone receptor (PR) ≤ 10%
Required: HER2 (ERBB2) wild-type (negative)
HER2-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH))
Excluded: BRCA1 germline mutation
Individuals with germline breast cancer gene (BRCA) mutations
Excluded: BRCA2 germline mutation
Individuals with germline breast cancer gene (BRCA) mutations
Disease stage
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0-1
Prior therapy
Must have received: neoadjuvant therapy — preoperative
residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery
Must have received: surgery — breast and/or lymph nodes
adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes
Must have received: radiation therapy
Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment
Cannot have received: stimulatory or coinhibitory T-cell receptor agent (CTLA-4, OX-40, CD137)
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))
Cannot have received: HER2-targeted therapy
prior treatment with any HER2-directed agent
Cannot have received: endocrine therapy
Exception: endocrine therapy ≤ 4 weeks allowed; planned concurrent endocrine therapy while receiving on-study treatment excluded
prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment
Cannot have received: topoisomerase 1 inhibitor
Prior treatment with topoisomerase 1 inhibitors
Cannot have received: antibody-drug conjugate containing a topoisomerase inhibitor
Prior treatment with antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
No 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 LVEF < 50%
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%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Alabama Oncology · Birmingham, Alabama
- Clearview Cancer Institute · Huntsville, Alabama
- Palo Verde Hematology Oncology · Glendale, Arizona
- Mayo Clinic Hospital · Phoenix, Arizona
- Arizona Oncology Associates · Prescott Valley, Arizona
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05633654 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior stimulatory or coinhibitory T-cell receptor agent, HER2-targeted therapy, endocrine therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 germline mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 germline mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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