Status:
COMPLETED
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen re...
Eligibility Criteria
Inclusion
- Histologically-confirmed diagnosis of invasive breast cancer, previously untreated
- Patients must be postmenopausal
- Candidates for mastectomy or breast-conserving surgery
- Primary tumor of above 2 cm diameter, measured by imaging
- Clinical Stage M0
- WHO performance status ≤1
- Adequate bone marrow, liver, and renal function
Exclusion
- Multicentric invasive tumors
- Bilateral or inflammatory breast cancer
- Receiving concomitant anti-cancer treatments such as chemotherapy
- Patients with an uncontrolled infection
- Patients with other concurrent severe and/or uncontrolled medical disease
- Additional protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00107016
Start Date
March 1 2005
End Date
April 1 2007
Last Update
March 4 2013
Active Locations (46)
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1
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
2
Breastlink Medical Group Inc.
Long Beach, California, United States, 90806
3
UCSF Breast Care Center
San Francisco, California, United States, 94115
4
University of Miami
Miami, Florida, United States, 33136