TITRE Une étude de détermination et d’expansion de la dose ouverte de phase Ib/II multicentrique, de type modulaire visant à examiner l’innocuité, la tolérance et l’activité antitumorale du trastuzumab deruxtecan (T-DXd) en association avec d’autres agents anticancéreux chez les patients atteints d’un cancer du sein métastatique HER2-positif.
PROTOCOLE ID DB-07 (DESTINY-Breast07)
CLINICAL TRIAL.gov ID NCT04538742
TYPE(S) DE CANCER Sein
PHASE Phase I-II
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Julie Lemieux
COORDONATEUR(RICE) Fanie Bourgault
fanie.bourgault@crchudequebec.ulaval.ca
418-525-4444 poste 82697
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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
CRITÈRES D'EXCLUSION (EN)
  • 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