Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
NCT02732119 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2021-05-05
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
Conditions
Interventions
- DRUG
-
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
- DRUG
-
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
- DRUG
-
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-14
- Primary Completion
- 2020-02-25
- Completion
- 2020-02-25
Countries
- United States
Study Locations
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