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

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT02732119

Run by

Novartis Pharmaceuticals

People needed

104

Starts

2016-06-14

Expected to finish

2020-02-25

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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