OncoMatch/Clinical Trials/NCT06238921
Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases
Is NCT06238921 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Zimberelimab and Sacituzumab govitecan for breast cancer.
Treatment: Zimberelimab · Sacituzumab govitecan — This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 ≤ 10% expression by IHC (≤ 10%)
a breast cancer must express (≤ 10%), by immunohistochemistry (IHC), of the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR])
Required: PR (PGR) ≤ 10% expression by IHC (≤ 10%)
a breast cancer must express (≤ 10%), by immunohistochemistry (IHC), of the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR])
Required: HER2 (ERBB2) negative (negative)
Triple negative breast cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: taxane
Prior treatment with taxane based chemotherapy
Must have received: anthracycline
Prior treatment with...anthracyclines
Cannot have received: topoisomerase 1 inhibitor
Exception: in the setting of brain metastases
Have previously received topoisomerase 1 inhibitors in the setting of brain metastases
Cannot have received: anticancer biologic agent
Exception: within 4 weeks prior to enrollment
Have had a prior anticancer biologic agent within 4 weeks prior to enrollment
Cannot have received: chemotherapy
Exception: within 2 weeks prior to enrollment and have not recovered
have had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to enrollment and have not recovered
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks prior to enrollment and have not recovered
have had prior chemotherapy, targeted small molecule therapy within 2 weeks prior to enrollment and have not recovered
Lab requirements
Cardiac function
No myocardial infarction or unstable angina pectoris within 6 months; no serious ventricular arrhythmia, high-grade AV block, or other cardiac arrhythmias requiring antiarrhythmic medications (except well-controlled atrial fibrillation); no NYHA Class III or greater CHF or LVEF < 40%
Met any of the following criteria for cardiac disease: 1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment 2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation 3. New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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