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

• Status: Completed
• Trial end date: 2020-02-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Exemestane; Sirolimus

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.