Clinical trial · Interventional
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women
NCT00107016CI-TRIAL-00009621completedPhase 2ClinicalTrials.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 examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole 2.5mg | Drug | Letrozole | ALIAS |
| RAD001, Letrozole 2.5mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RAD001 + letrozole 2.5mg
- interventionNames
- Drug: RAD001, Letrozole 2.5mg
- type
- ACTIVE_COMPARATOR
- label
- Letrozole 2.5mg
- interventionNames
- Drug: Letrozole 2.5mg
Primary outcomes (1)
- measure
- To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
Secondary outcomes (1)
- measure
- To assess the four month treatment as being predictive of clinical tumor response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed diagnosis of invasive breast cancer, previously untreated * Patients must be postmenopausal * Candidates for mastectomy or breast-conserving surgery * Primary tumor of above 2 cm diameter, measured by imaging * Clinical Stage M0 * WHO performance status ≤1 * Adequate bone marrow, liver, and renal function Exclusion Criteria: * Multicentric invasive tumors * Bilateral or inflammatory breast cancer * Receiving concomitant anti-cancer treatments such as chemotherapy * Patients with an uncontrolled infection * Patients with other concurrent severe and/or uncontrolled medical disease Additional protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDBaselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, Campone M, Kubista E, Greil R, Bianchi G, Steinseifer J, Molloy B, Tokaji E, Gardner H, Phillips P, Stumm M, Lane HA, Dixon JM, Jonat W, Rugo HS. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol. 2009 Jun 1;27(16):2630-7. doi: 10.1200/JCO.2008.18.8391. Epub 2009 Apr 20. PMID 19380449