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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00107016 record still lists

NCT00107016 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 153-participant average among 26 other Breast Neoplasm trials with a reported enrollment target (75% higher).

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 names 20 study sites across 10 states, led by 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.

Similar trials for Breast Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00107016's enrollment target sits among peer trials

267 6th of 26 higher than 21 of 26 other Breast Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00107016, the US trial registry maintained by the National Library of Medicine. NCT00107016 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.