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

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)

Trial Details

NCT ID
NCT06533826
Phase
PHASE2
Sponsor
Ana C Garrido-Castro, MD
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Trastuzumab Deruxtecan
  • Datopotamab Deruxtecan
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • San Francisco, California, United States|37.77493,-122.41942
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. P…
  • The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2 in a CLIA-certified environment. …
  • Participants must have history of HER2-low or HER2-0 breast cancer per local testing, and no known history of HER2-positive breast cancer. All avai…
  • HER2-low status is defined as IHC 1+ or 2+/ISH non-amplified breast cancer in any prior tumor sample (e.g., primary or metastatic tumor) collected …

For full eligibility, visit ClinicalTrials.gov.

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