A Randomized Study of mTOR Inhibition by RAD001 (Everolimus) in Invasive Breast Cancer Patients After Pre-operative Use of Anthracycline and/or Taxane-based Chemotherapy
Inclusion Criteria:
- Women aged ≥ 18 years;
- Histologically and/or cytologically confirmed invasive ductal or lobular breast
cancer;
- Tumor of 3 cm or greater at time of diagnosis
- Measurable primary tumor after neoadjuvant treatment before randomization
- No prior chemotherapy for breast cancer;
- ECOG performance status ≤1 or Karnofsky performace status ≥ 70%
- Adequate liver/renal function
- Able to swallow whole tablets.
- Able to give written informed consent
- Able to follow prescription instructions reasonably well
Exclusion Criteria:
- Male patient
- Prior history of other malignancy within 5 years of study entry, aside from
contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or
adequately treated basal or squamous cell carcinoma of the skin
- Distant metastasis, including skin involvement beyond the breast area
- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study