Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
Have radiologic evidence of disease progression or recurrence either
* On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial therapy for advanced disease, or
* On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early stage breast cancer
Must be deemed appropriate for treatment with ET
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable 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
You may not be if
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
Have symptomatic or untreated central nervous system metastasis
Have received any systemic therapy between disease recurrence/progression and study screening
Have received more than 1 line of therapy for advanced or metastatic disease.
Have received prior chemotherapy for metastatic breast cancer (MBC)
Have received prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders \[SERDs\] and non-SERDs), any phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or protein kinase B (AKT)-inhibitor
