C4391022

1) Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.

2) Documented estrogen receptor (ER) and/or progesterone receptor (PR)- positive tumor.

3) Documented HER2-negative tumor.

4) Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.

5) Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.

6) Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.

7) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.

1) Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.

2) In visceral crisis at risk of immediately life-threatening complications in the short term.

3) Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.

4) Prior treatment with any of the following:
|— a) Everolimus or investigational anti-cancer agents in any setting.
|— b) Prior chemotherapy in the advanced setting.
|— c) Radiation within 2 weeks of randomization.
|— d) Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5′ diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).

5) Inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

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