Titre A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting
Protocole ID DESTINY-Breast06
ClinicalTrials.gov ID NCT04494425
Type(s) de cancer Sein
Phase Phase III
Type étude Clinique
Médicament Trastuzumab Deruxtecan versus traitement au choix de l'investigateur
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dr Jamil Asselah
Coordonnateur(trice) Neera Sriskandarajah
514-934-1934 poste 36686
Statut Actif en recrutement
Critètes d'éligibilité
  • Patients must be ≥18 years of age
  • Pathologically documented breast cancer that:
    • is advanced or metastatic
    • has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
    • has HER2-low or HER2 IHC >0 <1+ expression
    • was never previously HER2-positive
    • is documented HR+ disease in the metastatic setting.
    • No prior chemotherapy for advanced or metastatic breast cancer.
    • Has adequate tumor samples for assessment of HER2 status
    • Must have either:
      • disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
      • disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the ≥2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
    • Has protocol-defined adequate organ and bone marrow function
Critètes d'exclusion
  • Ineligible for all options in the investigator's choice chemotherapy arm
  • Lung-specific intercurrent clinically significant illnesses
  • Uncontrolled or significant cardiovascular disease or infection
  • Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Patients with spinal cord compression or clinically active central nervous system metastases
  • Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment