RecruitingPhase 1Phase 2NCT06238921

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

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

31 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — sacituzumab govitecan and zimberelimab — together with targeted brain radiation (stereotactic radiosurgery, or SRS) for people with triple-negative breast cancer that has spread to the brain. Triple-negative breast cancer is an aggressive form that has limited treatment options, and brain metastases are a serious complication. **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer - Your cancer has spread to the brain (confirmed by MRI or surgery) - You are eligible for stereotactic radiosurgery (SRS) to brain tumors - The largest brain tumor is 4 cm or smaller in diameter - Your general health status allows treatment (ECOG 0–2) - You have previously received taxane-based chemotherapy with anthracyclines **You may NOT be eligible if...** - Your brain tumors are too large or too numerous for SRS - You have uncontrolled or very symptomatic brain tumors not manageable with low-dose steroids - You are pregnant or not willing to use contraception - You do not meet blood count or organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Radiation

Stereotactic Radiation to intact brain metastases or post-operative cavity.

DRUGZimberelimab

One week +/- 4 days following receipt of SRS, zimberelimab 360 mg IV will be administered. This will be followed by zimberelimab 360 mg IV every 3 weeks.

DRUGSacituzumab govitecan

SG will be administered on days 1 and 8 (10 mg/kg) of 21 day treatment cycles. This will be one week +/- 4 days following receipt of SRS for the first dose.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06238921


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