Titre A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
Protocole ID pionERA Breast Cancer
ClinicalTrials.gov ID NCT06065748
Type(s) de cancer Sein
Phase Phase III
Type étude Clinique
Médicament Giredestrant comparé au fulvestrant
Institution CISSS DES LAURENTIDES
   HOPITAL DE SAINT-JEROME
      290 Rue de Montigny, Saint-Jérôme, QC, J7Z 5T3
Ville Saint-Jérôme
Investigateur(trice) principal(e) Dr Ghislain Cournoyer
Coordonnateur(trice) Yanick Sardin Laframboise
 450-431-1020 poste 23429
Statut Actif en recrutement
Date d'activation 23-02-2024
Critètes d'éligibilité
  • Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or archived tumor sample)
  • Confirmed ESR1 mutation status (ESR1m vs. ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
  • Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed.
  • No prior systemic anti-cancer therapy for advanced disease
  • Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • For pre/perimenopausal women and for men: treatment with LHRH agonist therapy (as per local guidelines) for the duration of study treatment is required
Critètes d'exclusion
  • Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
  • Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  • Active cardiac disease or history of cardiac dysfunction
  • Clinically significant history of liver disease