Study on Sacituzumab Govitecan and Zimberelimab with Radiation for Treating Metastatic Triple Negative Breast Cancer with Brain Metastases
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT06238921
This clinical trial is testing a new treatment combination of Sacituzumab Govitecan and Zimberelimab with targeted brain radiation to see if it is safe and effective for patients with metastatic triple negative breast cancer that has spread to the brain.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if combining the drugs Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) can better manage metastatic triple negative breast cancer with brain metastases compared to using Sacituzumab Govitecan alone. The study aims to evaluate the safety and effectiveness of this combination treatment.
Eligibility Criteria
Inclusion Criteria
- Must provide signed and dated consent to participate.
- Willing to follow all study procedures and available for the study duration.
- Age 18 or older.
- Diagnosed with triple negative breast cancer, meaning the cancer does not express certain hormone receptors.
- Cancer has spread to the brain, confirmed by MRI or surgery.
- Eligible for targeted brain radiation (SRS).
- Have measurable brain tumors that can be tracked by scans.
- Largest brain tumor must be 4 cm or smaller.
- In good general health with a performance status score of 0 to 2.
- If having symptoms, must have had surgery or be on a stable dose of steroids (8 mg/day or less).
- Previously treated with certain chemotherapy drugs.
- Can have had previous brain radiation if there is still active disease.
- Women of childbearing age must have a negative pregnancy test before each treatment.
- Men and women of childbearing potential must agree to use contraception.
Exclusion Criteria
- Have cancer spread to the lining of the brain and spinal cord.
- Pregnant or breastfeeding women.
- Have HIV with a detectable viral load.
- Have active or suspected autoimmune diseases, except for certain stable conditions.
- Have a history of lung inflammation requiring steroids or current lung disease.
- Have serious heart conditions, such as recent heart attack or severe heart failure.
- Require oxygen therapy.
- Have a serious infection needing antibiotics.
- Have active inflammatory bowel disease or recent bowel perforation.
- Have had other cancers, unless they are in remission and not being treated for at least 2 years.
- Have a medical condition that increases risk or affects study results.
- Have not recovered from major surgery or injury within 14 days before starting the study.
- Have had recent cancer treatments and not fully recovered.
- Have used investigational drugs recently.
- Have active hepatitis B or C with detectable viral loads.
- Have allergies to study drugs.
- Are prisoners or involuntarily incarcerated.
- Are detained for psychiatric or infectious disease treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
