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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.

Phase 1/2RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT06238921Data as of May 2026

Treatment: Zimberelimab · Sacituzumab govitecanThis 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.

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Extracted 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

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