Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

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

Eligibility Criteria

Inclusion Criteria:

- 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
cancer

- 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.

Exclusion Criteria:

- 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
completion.

- Clinically significant, uncontrolled heart disease and/or recent cardiac events.

Principal Investigator

Qamar Khan

Study Contact

Novartis Pharmaceuticals, 1-888-669-6682

Estimated Completion Date

Friday, May 25, 2018

ClinicalTrials.gov #

NCT02732119
02/26/2017