| TITRE |
Étude ouverte de phase III à répartition aléatoire visant à comparer l’imlunestrant adjuvant et une endocrinothérapie adjuvante de référence chez des patients ayant déjà reçu une endocrinothérapie adjuvante pendant 2 à 5 ans pour le traitement d’un cancer du sein au stade précoce exprimant des récepteurs d’œstrogènes (RE+), HER2- associé à un risque accru de récidive. |
| PROTOCOLE ID |
EMBER-4 |
| CLINICAL TRIAL.gov ID |
NCT05514054 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DU NORD-DE-L'ILE-DE-MONTREAL
555 boulevard Gouin O
(514) 331-3020
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Isabelle Gingras
|
| COORDONATEUR(RICE) |
Marie-Anne Capobianco
marie-anne.capobianco@crhsc.rtss.qc.ca
514-338-2222 poste 3493
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
