Lead Sponsor

Eli Lilly and Company

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

•Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
•Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
•Have postmenopausal status
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
•Have adequate organ function
•Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy
•Are able to swallow oral formulation

•Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
•Have clinical evidence or history of central nervous system metastasis.
•Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitor.
•Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted.
•Have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
•Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
•Have received an autologous or allogeneic stem-cell transplant
•Have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). Screening is not required for enrolment.
•Are pregnant or breastfeeding.

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