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Completed

NCT Number: NCT00107016

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 receptor positive breast cancer.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Additional protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

RAD001, Letrozole 2.5mg

Drug

Letrozole 2.5mg

Drug

Primary outcomes

  1. To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women

Secondary outcomes

  1. To assess the four month treatment as being predictive of clinical tumor response

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 5, 2005
Registry last updated
Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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