Clinical trial · Interventional
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer
NCT02712723CI-TRIAL-00105276FELINEactive not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Placebo + Letrozole
- description
- Placebo randomized to 3 capsules/day 3 weeks on/1week off or 2 capsules/day continuous dosing + Letrozole 2.5 mg PO daily
- interventionNames
- Drug: Letrozole
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Ribociclib 600 mg + Letrozole
- description
- Ribociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily
- interventionNames
- Drug: Letrozole
- Drug: Ribociclib
- type
- EXPERIMENTAL
- label
- Ribociclib 400 mg + Letrozole
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.