RecruitingPhase 2NCT06533826

TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy


Sponsor

Ana C Garrido-Castro, MD

Enrollment

357 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer. The names of the study drugs involved in this study are: * Datopotamab deruxtecan (a type of antibody drug conjugate) * Trastuzumab deruxtecan (a type of antibody drug conjugate)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (TRADE DXd) tests two antibody-drug conjugates (ADCs) — dato-DXd and T-DXd — in patients with HER2-low or HER2-negative (HER2-0) metastatic breast cancer whose cancer has already stopped responding to a prior ADC (a type of targeted therapy that delivers chemotherapy directly to cancer cells). The study aims to find out which ADC works best after another one has failed, helping identify the best treatment sequence for this type of breast cancer. **You may be eligible if...** - You have invasive breast cancer that is advanced or has spread and cannot be surgically removed - Your breast cancer is HER2-low (IHC 1+ or 2+/non-amplified) or HER2-0 (IHC 0) — confirmed on any prior tumor sample - You have previously received an ADC (antibody-drug conjugate) for your breast cancer - Your hormone receptor status (ER/PR) can be positive or negative - You have measurable disease on a scan **You may NOT be eligible if...** - Your cancer is HER2-positive (IHC 3+ or amplified) now or at any point in history - You have not had prior ADC therapy - Your organ function does not meet minimum requirements - You have active uncontrolled brain metastases 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

DRUGTrastuzumab Deruxtecan

A HER2-directed ADC, 100mg/vial, via intravenous (into the vein) infusion per protocol.

DRUGDatopotamab Deruxtecan

A TROP2-directed antibody drug conjugate, 100mg/vial, via intravenous (into the vein) infusion per protocol.


Locations(11)

University of Alabama

Birmingham, Alabama, United States

University of San Francisco

San Francisco, California, United States

Yale University Cancer Center

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Vanderbilt Cancer Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06533826


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