EMBER-4: A Randomized, Open-Label, Phase III 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
Details
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.
Eligibility
You can join if...
Inclusion Criteria:
-Participant must be 18 years of age at the time of singing the informed consent
-Participant must have diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis
Participant must be able to swallow capsules or tablets
Exclusion Criteria:
Participant who is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trail, starting with the screening visit through 180 days after the last dose of study intervention
Participants who have a history of any other cancer (except non-melanoma skin cancer, stage I uterine cancer, or carcinoma in situ of the cervix or other in-situ cancer), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization
Participants who have had major surgery within 14 days prior to randomization