DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
NCT06176261 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2025-07-30
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)
Conditions
- Breast Cancer
- Breast Cancer Female
- Metastatic Triple-Negative Breast Carcinoma
- ER Positive Breast Cancer
- HER2-negative Breast Cancer
- HER2 Negative Breast Carcinoma
- ER-negative Breast Cancer
Interventions
- DRUG
-
Antibody-drug conjugate, 100 mg single-use vial, via intravenous infusion per protocol.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sarah Sammons, MD
lead OTHER
Principal Investigators
-
Sarah Sammons, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-08
- Primary Completion
- 2028-01-01
- Completion
- 2029-01-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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