EMBER-4: 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.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    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
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    (1) Participants have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis. (2) Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation. (3) Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor. (4) Must have an increased risk of disease recurrence based on clinical-pathological risk features. (5) Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale. (6) Have adequate organ function.

You may not be eligible for this study if the following are true:

  • (1) Participants have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis. (2) Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET. (3) Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening. (4) Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago. (5) 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. (6) Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene. (7) Participants with a history of any other cancer. (8) Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

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