Breast Cancer Clinical Trial

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

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

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Full Description

This trial had two phases. The purpose of Phase I dose escalation and dose de-escalation was to determine the maximum tolerated doses (MTDs) and/or identify the recommended Phase II dose (RP2D) of the combination treatment of ribociclib+ everolimus + exemestane. The dosing was continuous in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer which was resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.

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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

104

Study ID:

NCT02732119

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 24 Locations for this study

See Locations Near You

Ironwood Cancer and Research Centers Ironwood Cancer
Chandler Arizona, 85224, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
UCLA Department of Medicine UCLA Hematology/Oncology
Los Angeles California, 90095, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco California, 94115, United States
Central Coast Medical Oncology Corporation Onc Dept
Santa Maria California, 93454, United States
Yale University School of Medicine Smilow Cancer Hospital
New Haven Connecticut, 06511, United States
Florida Cancer Research Institute Dept of Oncology
Davie Florida, 33328, United States
Florida Cancer Specialists FL Cancer Specialists
Fort Myers Florida, 33901, United States
UF Health Cancer Center at Orlando Health UF Health (4)
Orlando Florida, 32806, United States
Florida Cancer Specialists-North
Saint Petersburg Florida, 33705, United States
Atlanta Cancer Center
Atlanta Georgia, , United States
University of Kansas Cancer Center Univ of KS CC Medical Pavilion
Westwood Kansas, 66205, United States
Massachusetts General Hospital Mass Gen Hos Cancer Center
Boston Massachusetts, 02114, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
St. Luke's Cancer Institute Regulatory
Kansas City Missouri, 64111, United States
Research Medical Center HCA Midwest Division
Kansas City Missouri, 64132, United States
Washington University School of Medicine Washington U School of Medicin
Saint Louis Missouri, 63110, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Penn State Hershey Cancer Institute
Hershey Pennsylvania, 17033, United States
University of Pennsylvania Medical Center Abramson Cancer Ctr of the Uni
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Research Institute Sarah Cannon Research Insti
Nashville Tennessee, 37203, United States
Oncology Consultants Oncology Consultants
Houston Texas, 77024, United States
MD Anderson Cancer Center/University of Texas MDACC
Houston Texas, 77030, United States
Huntsman Cancer Institute Huntsman Cancer Insti
Salt Lake City Utah, 84112, United States
Northwest Medical Specialties Dept of Onc
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

104

Study ID:

NCT02732119

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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