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
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.
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.
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There are 24 Locations for this study
Chandler Arizona, 85224, United States
Fayetteville Arkansas, 72703, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Santa Maria California, 93454, United States
New Haven Connecticut, 06511, United States
Davie Florida, 33328, United States
Fort Myers Florida, 33901, United States
Orlando Florida, 32806, United States
Saint Petersburg Florida, 33705, United States
Atlanta Georgia, , United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Livingston New Jersey, 07039, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77024, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Tacoma Washington, 98405, United States
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