ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4/6 inhibitor and endocrine therapy. The names of the study drugs involved in this study are: * Elacestrant (a type of selective estrogen receptor degrader) * Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)

Trial Details

NCT ID
NCT07198724
Phase
PHASE1 / PHASE2
Sponsor
Sarah Sammons, MD
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Elacestrant
  • Trastuzumab Deruxtecan
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participants must have a histologically or cytologically confirmed diagnosis of HR+/HER2-low metastatic or unresectable locally advanced breast can…
  • Participants must have had prior CDK4/6 inhibitor and either:
  • Disease progression on or within 12 months of endocrine therapy plus a CDK4/6 inhibitor in the adjuvant setting
  • One previous line of endocrine therapy in metastatic setting if disease progression within 6 months of first-line CDK4/6 plus endocrine treatment f…

For full eligibility, visit ClinicalTrials.gov.

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