Study on Letrozole with Ribociclib or Placebo as Pre-Surgery Treatment for ER-positive, HER2-negative Early Breast Cancer
Sponsor: Qamar Khan
ClinicalTrials ID:NCT02712723
This clinical trial is testing whether adding ribociclib to letrozole before surgery can improve outcomes for women with early-stage ER-positive, HER2-negative breast cancer, potentially reducing the need for chemotherapy.
Patient Parameters
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Program Overview
The study aims to find out if combining ribociclib with letrozole for 24 weeks before surgery can lead to better results for women with early-stage ER-positive, HER2-negative breast cancer. Researchers want to see if this combination increases the number of women who achieve a Pre-operative Endocrine Prognostic Index (PEPI) score of 0, which indicates excellent outcomes without needing chemotherapy, compared to using letrozole alone.
Description
Participants in this study will be randomly assigned to one of three groups: one group will receive letrozole with a placebo, another group will receive letrozole with continuous ribociclib, and the third group will receive letrozole with ribociclib on an intermittent schedule (3 weeks on, 1 week off). The study will compare the responses to these treatments by looking at clinical, pathologic, and radiologic outcomes, as well as PEPI scores. Participants will be monitored for 5 years after treatment to see if the combination of ribociclib and letrozole improves the chances of staying cancer-free compared to letrozole alone.
Eligibility Criteria
Inclusion Criteria
- Women diagnosed with invasive breast cancer through a biopsy.
- Must be 18 years or older and postmenopausal.
- Have a good performance status with an ECOG score between 0 and 2.
- The breast cancer must be ER-positive in at least 66% of the cells or have an ER Allred score of 6-8.
- The breast cancer must be HER2-negative.
- Cancer must be at clinical stage II or III based on exams or imaging.
Exclusion Criteria
- Currently using other experimental treatments.
- Have inflammatory breast cancer, which includes significant redness of the breast or certain skin changes.
- Have had an excisional biopsy for this breast cancer.
- Have had any surgical procedure to check lymph nodes before joining the study.
- Have used hormone replacement therapy, megestrol acetate, or raloxifene within four weeks before starting the study.
- Have signs of cancer spreading to other parts of the body.
- Have uncontrolled heart disease.
- Using certain herbal preparations or medications listed in the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| City of Hope National Medical Center | 91010 | Duarte | California |
| Cancer Research Collaboration | 92705 | Santa Ana | California |
| University of Miami Sylvester Comprehensive Cancer Center | 33442 | Deerfield Beach | Florida |
| University of Kansas Cancer Center - West | 66112 | Kansas City | Kansas |
| University of Kansas Cancer Center - Overland Park | 66210 | Overland Park | Kansas |
| University of Kansas Cancer Center - Westwood | 66205 | Westwood | Kansas |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| University of Kansas Cancer Center - South | 64131 | Kansas City | Missouri |
| University of Kansas Cancer Center - North | 64154 | Kansas City | Missouri |
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