An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer (CRAD001Y24135)
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON41506
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
• Postmenopausal (>= 18 years) women with locally advanced or metastatic breast cancer not amenable to curative treatment. Postmenopausal status definition: see protocol page 27 for details
• No prior treatment for metastatic breast cancer.
• Must have measurable disease (see protocol page 27) or non-measurable lytic or mixed (lytic + sclerotic) bone lesions.
• ECOG performance status 0-2.
• Prior hormonal or any other systemic therapy for metastatic breast cancer. Prior neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
• Previous treatment with mTOR inhibitors.
• HRT unless discontinued prior to enrollment.
• Evidence of CNS metastases.
• Chronic treatment with systemic immunosuppressive agents.
• Bilateral diffuse lymphangitic carcinomatosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival in the 1st line.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall response rate, clinical benefit rate, overall survival in the 1st line<br /><br>setting, progression free survival and clinical benefit rate in the 2nd line<br /><br>setting, safety and tolerability. Severity and duration of stomatitis after<br /><br>therapeutic intervention.</p><br>