Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-25 @ 8:08 PM
Study NCT ID:
NCT06176261
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2023-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
Sponsor:
Sarah Sammons, MD
Organization:
Study Overview
Official Title:
DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: