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NCT00107016 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Neoplasm, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
267
Enrollment target
20
Study locations

NCT00107016 is a Phase 2 study of Breast Neoplasm that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 267 participants, above the 153-participant average among 26 other Breast Neoplasm trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT00107016, a Phase 2 study of Breast Neoplasm, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
267 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Letrozole 2.5mg
  • DRUG RAD001, Letrozole 2.5mg

Study Locations (20)

Other

  • Novartis Investigative Site - Salzburg
  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Wilrijk
  • Novartis Investigative Site - Natasha
  • Novartis Investigative Site - Winnipeg
  • Novartis Investigative Site - Besançon
  • Novartis Investigative Site - Bordeaux
  • Novartis Investigative Site - Montpellier
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Saint-Herblain

California

  • Breastlink Medical Group Inc. - Long Beach
  • UCSF Breast Care Center - San Francisco

Arkansas

  • Highlands Oncology Group - Springdale

Florida

  • University of Miami - Miami

Illinois

  • Loyola University Medical Center - Maywood

Indiana

  • Investigative Clinical Research of Indiana - Indianapolis

Louisiana

  • Ochsner Clinic Foundation - New Orleans

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2005-03
Est. Completion 2007-04
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00107016

The ClinicalTrials.gov registry entry for NCT00107016 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 153-participant average among 26 other Breast Neoplasm trials with a reported enrollment target (75% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Letrozole 2.5mg is the first listed.

NCT00107016 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00107016 about?

NCT00107016 is a clinical study titled "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.

What is the current status of trial NCT00107016?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 267 participants. The study started on 2005-03. Estimated completion is 2007-04.

What conditions does trial NCT00107016 study?

This clinical trial studies the following conditions: Breast Neoplasm.

What interventions are being tested in trial NCT00107016?

The interventions under investigation include: Letrozole 2.5mg (DRUG), RAD001, Letrozole 2.5mg (DRUG).

Who is sponsoring clinical trial NCT00107016?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00107016 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.