Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
NCT ID: NCT02732119
Last Updated: 2021-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
104 participants
INTERVENTIONAL
2016-06-14
2020-02-25
Brief Summary
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Detailed Description
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The purpose of the phase II portion of this trial was to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib combination therapy following progression on a CDK 4/6 inhibitor.
The planned duration of the study was 30 months.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
Ribociclib
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimus
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Cohort B
Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
Ribociclib
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimus
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Cohort C
Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
Ribociclib
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimus
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Group 1
Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
Ribociclib
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimus
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Group 2
Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
Ribociclib
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimus
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Interventions
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Ribociclib
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimus
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestane
supplied in 25 mg tablets taken orally, daily for 28 day cycle
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer and Research Centers Ironwood Cancer
Chandler, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
UCLA Department of Medicine UCLA Hematology/Oncology
Los Angeles, California, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, United States
Central Coast Medical Oncology Corporation Onc Dept
Santa Maria, California, United States
Yale University School of Medicine Smilow Cancer Hospital
New Haven, Connecticut, United States
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, United States
Florida Cancer Specialists FL Cancer Specialists
Fort Myers, Florida, United States
UF Health Cancer Center at Orlando Health UF Health (4)
Orlando, Florida, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, United States
Atlanta Cancer Center
Atlanta, Georgia, United States
University of Kansas Cancer Center Univ of KS CC Medical Pavilion
Westwood, Kansas, United States
Massachusetts General Hospital Mass Gen Hos Cancer Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
St. Luke's Cancer Institute Regulatory
Kansas City, Missouri, United States
Research Medical Center HCA Midwest Division
Kansas City, Missouri, United States
Washington University School of Medicine Washington U School of Medicin
St Louis, Missouri, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
University of Pennsylvania Medical Center Abramson Cancer Ctr of the Uni
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute Sarah Cannon Research Insti
Nashville, Tennessee, United States
Oncology Consultants Oncology Consultants
Houston, Texas, United States
MD Anderson Cancer Center/University of Texas MDACC
Houston, Texas, United States
Huntsman Cancer Institute Huntsman Cancer Insti
Salt Lake City, Utah, United States
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLEE011XUS29
Identifier Type: -
Identifier Source: org_study_id
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