|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||CRAD001Y2301|
There are no treatments specifically approved after recurrence or progression on a NSAI. In light of the need for new treatment options for postmenopausal women after failure of prior non steroidal aromatase inhibitors (NSAI) therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.
- Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
- Postmenopausal women.
- Disease refractory to non steroidal aromatase inhibitors (NSAI),
- Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
- Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease
- Adequate bone marrow and coagulation function
- Adequate liver and renal function
- ECOG Performance Status = 2 or less
- HER2-overexpressing patients
- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
- Patients who received more than one chemotherapy line for Advanced Breast Cancer.
- Previous treatment with exemestane or mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
- Radiotherapy within four weeks prior to randomization
- Currently receiving hormone replacement therapy,
- Patients receiving immunosuppressive agents or chronic corticosteroids use
- Patients being treated with strong inhibitors or inducers of CYP3A within 5 days prior to randomization
Other protocol-defined inclusion/exclusion criteria may apply
Trial Lead Organizations/Sponsors
Novartis Pharmaceuticals Corporation
|Novartis Pharmaceuticals||Study Director|
|Novartis Pharmaceuticlas||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00863655
Information obtained from ClinicalTrials.gov on September 27, 2012
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