Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
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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 receptor positive breast cancer.
A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cancer of the Breast
Primary breast cancer
Additional relevant MeSH terms:
Neoplasms by Site
Physiological Effects of Drugs