Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women

Completed · Phase 2

Conditions studied: Breast Neoplasm

In brief

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.

Key facts

Study ID

NCT00107016

Run by

Novartis Pharmaceuticals

People needed

267

Starts

2005-03-01

Expected to finish

2007-04-01

Last updated by the study team

2013-03-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• UPMC / Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Natasha, Canada
• Novartis Investigative Site — Winnipeg, Canada
• Novartis Investigative Site — Besançon, France
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Saint-Herblain, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Erlangen, Germany
• Novartis Investigative Site — Frankurt Am Main, Germany
• Novartis Investigative Site — Jena, Germany
• Novartis Investigative Site — Kiel, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Regensburg, Germany
• Novartis Investigative Site — Tübingen, Germany
• Novartis Investigative Site — Florence, Italy
• Novartis Investigative Site — Milan, Italy
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Torino, Italy

Full record on ClinicalTrials.gov

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