Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
Sponsor: Qamar Khan
ClinicalTrials ID:NCT02712723
This study evaluates the efficacy of ribociclib with letrozole as neoadjuvant therapy in ER-positive, HER2-negative early breast cancer. Participants, all postmenopausal women with confirmed invasive cancer, are randomized to three groups: letrozole with placebo, continuous ribociclib, or intermittent ribociclib. The trial assesses PEPI scores, clinical responses, and 5-year RFS.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.
Description
Subjects will be randomized (1:1:1) to either letrozole plus placebo vs. letrozole plus continuous dosing of ribociclib vs. letrozole plus intermittent dosing (3-weeks-on/1-week-off) of ribociclib.
The difference in clinical, pathologic and radiologic response as well as Pre-operative Endocrine Prognostic Index (PEPI) scores across the three treatments arms will be examined. Subjects will also be followed for 5 years post-treatment to determine if ribociclib in combination with letrozole for 24 weeks results in improved 5 year Relapse Free Survival (RFS) compared to letrozole alone.
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed invasive breast cancer by core needle biopsy
- Female subjects, age ≥ 18 years
- Only postmenopausal women will be eligible.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-2
- Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8
- Invasive breast cancer must be HER2 negative.
- Clinical Stage II or III (by clinical measurement and/or breast imaging)
Key
Exclusion Criteria
- Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Current use of other investigational agents
- Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
- An excisional biopsy of this breast cancer
- Surgical axillary staging procedure prior to study entry
- Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment
- Clinical or radiographic evidence of metastatic disease
- Clinically significant, uncontrolled heart disease
- Herbal preparations/medications as listed in Appendix B of the 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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