Trial details
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
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: EMBER-4
Official 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
Principal Investigator: Dr. Ellen Warner
Cancer type: Breast
Cancer location: Breast
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Drug: Imlunestrant, Drug: Tamoxifen, Drug: Anastrozole, Drug: Letrozole, Drug: Exemestane
Registration #:
NCT05514054 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
Inclusion 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.
