Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Protocole ID	AMEERA-5 (EFC15935)
ClinicalTrials.gov ID	NCT04478266
Type(s) de cancer	Sein
Phase	Phase III
Stade	Maladie avancée ou métastatique
Type étude	Clinique
Médicament	Amcenestrant + Palbociclib versus Letrozole + Palbociclib
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 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	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
Critètes d'exclusion	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.

Groupe d'étude en oncologie du Québec