Breast Cancer
Conditions
Interventions
Product Name: RAD001
Pharmaceutical Form: Coated tablet
Sponsors
Lothian Health - University Hospitals Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postmenopausal females, fresh tissue available from core biopsies taken at diagnosis, no evidence of metastatic disease, operable breast cancer, written informed consent from all subjects Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior therapy for breast cancer, inflammatory breast cancer, concurrent medical or psychiatric problems unrelated to breast cancer which would limit compliance, treatment with another investigational drug within 30 days or five half-lives prior to entry into the study, receiving or expected to require concurrent chemotherapy, immunotherapy, radiotherapy, chronic corticosteroid therapy or other hormonal therapy for breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the biological activity of RAD001 in human primary breast cancers using immunohistochemical methods. The endpoints include its effects on proliferation and other markers known to be affected by RAD001;Secondary Objective: ;Primary end point(s): Changes in RAD markers, PAK/AKT immunohistochemistry, P4E-BP[4E-BP] immunohistochemistry, PTEN immunohistochemistry - equivocal cases on FISH, PTEN mutations using DNA probes and Western blotting, S6(40S) immunohistochemistry | — |
Countries
United Kingdom
Outcome results
None listed