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, Older Adult)
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:
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Neoplasms by Site
Physiological Effects of Drugs