A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole.
- Conditions
- Estrogen Receptor Positive Locally Advanced or Metastatic Breast CancerMedDRA version: 17.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2008-008698-69-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 705
•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 measuredor bone lesions in the absence of measurable disease
•Adequate bone marrow and coagulation function
•Adequate liver and renal function
•ECOG Performance Status = 2 or lessOther protocol-defined inclusion criteria may apply
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
• 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 exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method