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NCT00667251 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 652
- Enrollment target
- 20
- Study locations
NCT00667251 is a Phase 3 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 652 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT00667251, a Phase 3 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 652 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.
Conditions Studied
Interventions
- DRUG docetaxel
- DRUG paclitaxel
- BIOLOGICAL trastuzumab
- DRUG lapatinib ditosylate
Study Locations (20)
Connecticut
- Novartis Investigative Site - Greenwich
- Novartis Investigative Site - Southington
- Novartis Investigative Site - Stamford
- Novartis Investigative Site - Trumbull
- Novartis Investigative Site - Waterbury
California
- Novartis Investigative Site - Berkeley
- Novartis Investigative Site - Highland
- Novartis Investigative Site - Montebello
Florida
- Novartis Investigative Site - Kissimmee
- Novartis Investigative Site - Loxahatchee Groves
- Novartis Investigative Site - New Port Richey
Georgia
- Novartis Investigative Site - Augusta
- Novartis Investigative Site - Lawrenceville
- Novartis Investigative Site - Savannah
Colorado
- Novartis Investigative Site - Colorado Springs
- Novartis Investigative Site - Denver
Alaska
- Novartis Investigative Site - Anchorage
Arizona
- Novartis Investigative Site - Tucson
Arkansas
- Novartis Investigative Site - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 652 participants |
| Start Date | 2008-10-07 |
| Est. Completion | 2022-07-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00667251
The ClinicalTrials.gov registry entry for NCT00667251 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 652 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (77% lower). 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 Cancer appearing as the primary indexed condition, and to 4 interventions - of which docetaxel is the first listed.
NCT00667251 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Connecticut, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00667251 about?
NCT00667251 is a clinical study titled "Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer". This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metas...
What is the current status of trial NCT00667251?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2008-10-07. Estimated completion is 2022-07-27.
What conditions does trial NCT00667251 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00667251?
The interventions under investigation include: docetaxel (DRUG), paclitaxel (DRUG), trastuzumab (BIOLOGICAL), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00667251?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00667251 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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