Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 2
Funding Agency/Sponsor
Institutional
Disease
Breast Cancer
Enrollment Eligibility
Key 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