Breast Neoplasm
Conditions
Keywords
Breast Cancer, Cancer of the Breast, Neo-adjuvant, Primary breast cancer, postmenopausal, pre-operative
Brief summary
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.
Interventions
DRUGRAD001, Letrozole 2.5mg
DRUGLetrozole 2.5mg
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the four month treatment as being predictive of clinical tumor response | — |
Countries
Austria, Belgium, Canada, France, Germany, Italy, Russia, Spain, United Kingdom, United States
Outcome results
None listed