| 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 |
![]() Fermé |
| 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