| Title |
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 |
| Cancer Type(s) |
Breast |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Imlunestrant versus thérapie endocrinienne adjuvante standard |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Rami Younan
|
| Coordinator |
Ana Lydia Tkalec
514-890-8000 poste 14186
|
| Status |
Recruiting |
| Activation Date |
20-10-2023 |
| Eligibility Criteria |
- 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.
|
| Exclusion Criteria |
- 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.
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Groupe d'étude en oncologie du Québec