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

Status Recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Brain Neoplasms
Breast Cancer
Breast Cancer Female
Breast Neoplasms
Carcinoma
ER Positive Breast Cancer
ER-negative Breast Cancer
HER2 Negative Breast Carcinoma
HER2-negative Breast Cancer
Metastatic Triple-Negative Breast Carcinoma

Clinical Trial Details

NCT number	NCT06176261
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Sarah Sammons, MD
Phone	617-362-3800
Email	sarahl_sammons@dfci.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	December 26, 2023
Completion date	January 1, 2029

View Details

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