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Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
NCT00107016 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00107016
The ClinicalTrials.gov registry entry for NCT00107016 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00107016 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00107016?
The interventions under investigation include: Letrozole 2.5mg (DRUG), RAD001, Letrozole 2.5mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00107016?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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