RecruitingPhase 2NCT06750484

Trial of Trastuzumab Deruxtecan in Previously Treated HER2

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer


Sponsor

Yale University

Enrollment

40 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, in people with metastatic or unresectable breast cancer that has never tested positive for the HER2 protein in any prior testing — called HER2-zero breast cancer. **You may be eligible if...** - You are 18 or older - You have metastatic or unresectable breast cancer - All prior tumor biopsies have consistently shown HER2-zero status (no detectable HER2 protein at all) - You have never had a biopsy show HER2-positive or HER2-low results - You have hormone receptor-positive (HR+) breast cancer that has progressed after hormone therapy, or hormone receptor-negative (HR-) breast cancer **You may NOT be eligible if...** - Any of your previous biopsies showed any HER2 expression (even low levels) - Your cancer is still responding to hormone therapy - You have brain metastases that are unstable - 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

DRUGTrastuzumab Deruxtecan

Participants will receive the study drug trastuzumab deruxtecan (T-DXd) by IV infusion every 21 days. The number of treatment cycles will depend on how participants respond to treatment.


Locations(2)

Yale University

New Haven, Connecticut, United States

University of Rochester Medical Center

Rochester, New York, United States

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NCT06750484


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