NCT06176261 · Sarah Sammons, MD
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Datopotamab Deruxtecan
Antibody-drug conjugate, 100 mg single-use vial, via intravenous infusion per protocol.
Primary outcome measures
Objective Response Rate (ORR) in RANO-BM Criteria
Time frame: 3 years
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RANO-BM criteria defined protocol section 11.1.1.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Metastatic breast cancer that is pathologically confirmed to be HER2-negative according to 2018 ASCO/CAP guidelines 55.
- Radiological confirmation of metastatic disease.
- Cohorts A and B: Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and/or systemic therapy.
- Cohorts A and B: Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy and/or systemic therapy (in the opinion of the treating physician). For cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.
- Cohorts C: Radiological evidence of evaluable leptomeningeal diseas
Where
- Miami, Florida
- Boston, Massachusetts
- Durham, North Carolina
Collaborators
Daiichi Sankyo
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2025 · Source of record for eligibility and locations