RecruitingPhase 2NCT05866432

Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases


Sponsor

Medical University of Vienna

Enrollment

20 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate (a targeted drug linked to chemotherapy), in people with triple-negative breast cancer that has spread to the brain. **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer - You have brain metastases that are either newly diagnosed and untreated, or that have progressed after previous local treatment (such as radiation) - You are in reasonably good physical condition (ECOG 0–2) with a life expectancy of at least 3 months - Your organ function (bone marrow, liver, kidneys) is adequate - Prior immunotherapy and TROP-2 targeted therapy are allowed **You may NOT be eligible if...** - You have a known allergy to Dato-DXd or its components - You have had another cancer (other than skin cancers or cervical in situ) in the past 3 years - You are currently receiving other anti-cancer treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDatopotamab deruxtecan

Will be given until PD or withdraw


Locations(1)

AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology

Vienna, State of Vienna, Austria

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NCT05866432


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