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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: Completed Phase 3 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival (PFS) is the time from randomization to the earliest date of RECIST 1.0 assessment of disease progression (with radiological evidence), death from any cause, or censoring. Disease progression was assessed by the Investigator and defined by RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.
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 |
What the finished NCT00667251 record still lists
NCT00667251 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (77% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT00667251's enrollment target sits among peer trials
652 167th of 1224 higher than 1,058 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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