Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qamar Khan
• Collaborator: Novartis Pharmaceuticals
• Treatments: Letrozole

Criteria

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