NCT06176261

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Sarah Sammons, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a single-arm, multi-cohort, open-label, phase II trial designed to evaluate the safety and efficacy of datopotamab deruxtecan for the treatment of CNS metastases in patients with HER2-negative metastatic breast cancer. Participants will be enrolled in three different groups: Cohort A for estrogen receptor (ER)-positive HER2-negative breast cancer, Cohort B for metastatic triple negative breast cancer, and Cohort C for HER2-negative metastatic breast cancer which has spread to the leptomeninges (which surround the brain or spinal cord). Datopotamab deruxtecan is a new type of anti-cancer drug called an "antibody drug conjugate" (ADC) that targets cancer cells expressing a specific molecule on the tumor cell membrane. The U.S. Food and Drug Administration (FDA) has not approved datopotamab deruxtecan as a treatment for metastatic, Human epidermal growth factor receptor-2 (HER2) negative breast cancer. The research study procedures include screening for eligibility, blood tests, questionnaires, and study treatment visits, Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) scans, electrocardiograms, echocardiograms, and cerebral spinal fluid (CSF) collection. It is expected that about 58 people will take part in this research study. Daiichi Sankyo Inc. is funding this study and providing the study drug, datopotamab deruxtecan.

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

Type	Name	Description
DRUG	Datopotamab Deruxtecan	Antibody-drug conjugate, 100 mg single-use vial, via intravenous infusion per protocol.

Timeline

• Start date: 2024-01-08
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2023-12-19
• Last updated: 2025-07-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study