RecruitingPhase 2NCT06176261

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs


Sponsor

Sarah Sammons, MD

Enrollment

58 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (DATO-BASE) is testing an antibody-drug combination called datopotamab deruxtecan (Dato-DXd) in people with HER2-negative metastatic breast cancer that has spread to the brain, to see whether this drug can cross into the brain and shrink or control cancer there. **You may be eligible if...** - You are an adult with confirmed HER2-negative metastatic breast cancer - You have brain metastases (cancer that has spread to the brain) that are either newly diagnosed or progressing after prior treatment - You have at least one measurable brain lesion of 1 cm or larger on MRI - You are able to have an MRI (or head CT if MRI is not possible) **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You have leptomeningeal disease only (cancer coating the brain lining) without measurable brain lesions - You have had prior treatment with datopotamab deruxtecan or similar drugs - You have active autoimmune conditions requiring systemic treatment 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

DRUGDatopotamab Deruxtecan

Antibody-drug conjugate, 100 mg single-use vial, via intravenous infusion per protocol.


Locations(3)

Miami Baptist Cancer Institute/

Miami, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT06176261


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