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COMPLETEDPhase 2NCT00107016

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

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...

Lead sponsor: Novartis Pharmaceuticals•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novartis Pharmaceuticals

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 4, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment267

Start dateMar 2005

Last updatedMar 4, 2013

Condition

Breast Neoplasm

Locations shown

Highlands Oncology Group

Springdale, Arkansas

Breastlink Medical Group Inc.

Long Beach, California

UCSF Breast Care Center

San Francisco, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2013Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions