The purpose of this study is determine if the triplet combination of ribociclib, everolimus
and exemastane is effective in the treatment of locally advanced/metastatic breast cancer
following treatment with a CDK 4/6 inhibitor
- Adult men and women
- Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone
receptor positive breast cancer by local laboratory and has HER2-negative breast
- Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence
of measurable disease.
- ECOG Performance Status 0 - 1
- Disease refractory to either, AI, tamoxifen or fulvestrant
- Previously treated on any CDK 4/6 inhibitor.
- Patient has adequate bone marrow and organ function.
- Patient with symptomatic visceral disease or any disease burden that makes the
patient ineligible for endocrine therapy per the investigator's best judgment.
- Patient has received more than one line of chemotherapy for advanced disease.
- Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
- Progressed on more than one CDK 4/6 inhibitor
- Patient with CNS involvement unless they are at least 4 weeks from prior therapy
- Clinically significant, uncontrolled heart disease and/or recent cardiac events.