A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Korábbi kezelés

• Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor

Más betegség

• Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
• Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
• Known allergic reaction against any of the components of the study treatment

Egyéb

• Have symptomatic or untreated brain metastasis.

• Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
• Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
  • -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
• Must be deemed appropriate for treatment with endocrine therapy
• If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
• Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
• Have adequate renal, hematologic, and hepatic organ function
• Must be able to swallow capsules/tablets