A study to evaluate the biological effects of RAD001 on invasive breast cancer
- Conditions
- Breast Cancer
- Registration Number
- EUCTR2004-001712-31-GB
- Lead Sponsor
- othian Health - University Hospitals Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method