Titre A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
Protocole ID EMBER-4
ClinicalTrials.gov ID NCT05514054
Type(s) de cancer Sein
Phase Phase III
Type étude Clinique
Médicament Imlunestrant versus thérapie endocrinienne adjuvante standard
Institution CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL
   HOPITAL DU SACRE-COEUR-DE-MONTREAL
      5400 boul. Gouin Ouest, Montréal, QC, H4J1C5
Ville Montréal
Investigateur(trice) principal(e) Dre Isabelle Gingras
Coordonnateur(trice) Marie-Anne Capobianco
 514-338-2222 poste 3493
Statut Actif en recrutement
Date d'activation 23-10-2023
Critètes d'éligibilité
  • Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
  • Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
  • Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
  • Must have an increased risk of disease recurrence based on clinical-pathological risk features.
  • Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
  • Have adequate organ function.
Critètes d'exclusion
  • Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
  • Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
  • Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
  • Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
  • Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
  • Participants with a history of any other cancer.
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.