Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06238921

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-05

31

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

G

Gilead Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form (ICF) provided.
  • Willingness to comply with all study procedures and be available for the entire study.
  • Age 18 years or older.
  • Diagnosed with triple negative breast cancer defined by ≤10% hormone receptor expression.
  • Breast cancer confirmed by extracranial tumor biopsy with brain metastases confirmed by MRI or surgical pathology.
  • Eligible for stereotactic radiosurgery (SRS) to brain metastases or post-operative bed.
  • Measurable brain disease per RANO-BM criteria with at least one dimension ≥0.5 cm.
  • Largest intact brain metastasis diameter ≤4 cm.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Symptomatic patients who have had surgery or are on stable steroid doses ≤8 mg/day dexamethasone.
  • Prior treatment with taxane-based chemotherapy including anthracyclines.
  • Prior SRS/fractioned stereotactic radiotherapy allowed if active measurable disease not previously treated with radiation.
  • Women of childbearing potential must have negative pregnancy test within 24 hours before each dose.
  • Male and female patients of childbearing potential must agree to use effective contraception if sexually active with opposite sex.
Not Eligible

You will not qualify if you...

  • Presence of leptomeningeal disease.
  • Pregnant or breastfeeding women.
  • Known HIV-1 or HIV-2 with detectable viral load.
  • Active, known, or suspected autoimmune disease requiring immunosuppressive treatment (exceptions apply).
  • History or current pneumonitis/interstitial lung disease requiring steroids.
  • Recent myocardial infarction or unstable angina within 6 months.
  • History of serious ventricular arrhythmia or certain cardiac arrhythmias requiring medication.
  • New York Heart Association Class III or higher heart failure or left ventricular ejection fraction below 40%.
  • Need for supplemental oxygen therapy.
  • Active serious infection requiring antibiotics.
  • Active chronic inflammatory bowel disease or gastrointestinal perforation within 6 months.
  • Prior non-breast cancer malignancies except certain treated cancers in remission for 2+ years.
  • Medical conditions increasing risk or interfering with study participation.
  • Major surgery or significant injury not recovered from within 14 days before study drug.
  • Recent use of anticancer biologic agents, chemotherapy, or targeted therapy within specified timeframes.
  • Prior topoisomerase 1 inhibitors for brain metastases.
  • Use of other investigational drugs within 28 days or 5 half-lives.
  • Active Hepatitis B or C infection with detectable viral load.
  • Allergy or hypersensitivity to study drugs or components.
  • Prisoners or involuntarily incarcerated individuals.
  • Individuals compulsorily detained for psychiatric or physical illness treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

M

Michelle DeJesus

CONTACT

K

Kamran Ahmed, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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