Sein

TITRE Étude de phase III à répartition aléatoire, multicentrique et à double insu portant sur l’association amcénestrant (SAR439859) plus palbociclib par rapport à l’association létrozole plus palbociclib pour le traitement des patientes atteintes d’un cancer du sein ER(+), HER2(-) n’ayant pas reçu de traitement anticancéreux systémique antérieur pour une maladie avancée
PROTOCOLE ID AMEERA-5 (EFC15935)
CLINICAL TRIAL.gov ID NCT04478266
TYPE(S) DE CANCER Sein
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jamil Asselah
COORDONATEUR(RICE) Neera Sriskandarajah
neera.sriskandarajah@mail.mcgill.ca
514-934-1934 poste 36686
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • No prior systemic treatment for loco-regional recurrent or metastatic disease
  • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants should be willing to provide tumor tissue
  • Capable of giving informed consent
CRITÈRES D'EXCLUSION (EN)
  • Known active brain metastases
  • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
  • Inadequate organ and marrow function
  • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
  • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
  • Male participants who disagree to follow contraception
  • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
  • Participants with significant concomitant illness

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.