Titre A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)
Protocole ID DB-07 (DESTINY-Breast07)
ClinicalTrials.gov ID NCT04538742
Type(s) de cancer Sein
Phase Phase I-II
Stade Métastatique
Type étude Clinique
Médicament Trastuzumab deruxtecan
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DU SAINT-SACREMENT
      1050 Ch Ste-Foy, Québec, QC, G1S 4L8
Ville Québec
Investigateur(trice) principal(e) Dre Julie Lemieux
Coordonnateur(trice) Fanie Bourgault
418-525-4444 poste 82697
Statut Actif en recrutement
Critètes d'éligibilité
  • Patients must be at least 18 years of age
  • Pathologically documented breast cancer that:
    1. Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
    2. HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment
    3. Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
  • Patient must have adequate tumor sample for biomarker assessment
  • ECOG Performance Status of 0 or 1
  • Part 1
    1. Disease progression on or after the last systemic therapy prior to starting study treatment
    2. At least 1 prior treatment line in metastatic setting required.
  • Part 2 (Modules 0 - 5)
    a) No prior lines of therapy for advanced/MBC allowed
  • Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed
CNS Inclusion
  • Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
  • Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
Critètes d'exclusion
  • Uncontrolled or significant cardiovascular disease
  • Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Spinal cord compression or a history of leptomeningeal carcinomatosis
  • Prior treatment with immune checkpoint inhibitors
  • Prior treatment with an ADC containing a topoisomerase I inhibitor
  • Prior treatment with tucatinib
CNS Exclusion
  • Modules 0 - 5: Has untreated brain metastasis
  • Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases or brain lesion thought to require immediate local therapy