Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT00667251. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00667251
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 652 participants
Conditions and interventions
Conditions
Interventions
- trastuzumab Biological
- docetaxel Drug
- lapatinib ditosylate Drug
- paclitaxel Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2008 (Actual)
- Primary completion
- Aug 1, 2012 (Actual)
- Completion
- Jul 27, 2022 (Actual)
- Last update posted
- Mar 21, 2025
2008 – 2022
United States locations
- U.S. sites
- 53
- U.S. states
- 25
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Anchorage | Alaska | 99508 | — |
| Novartis Investigative Site | Tucson | Arizona | 85715 | — |
| Novartis Investigative Site | Hot Springs | Arkansas | 71913 | — |
| Novartis Investigative Site | Berkeley | California | 94704 | — |
| Novartis Investigative Site | Highland | California | 92346 | — |
| Novartis Investigative Site | Montebello | California | 90640 | — |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | — |
| Novartis Investigative Site | Denver | Colorado | 80204 | — |
| Novartis Investigative Site | Greenwich | Connecticut | 06830 | — |
| Novartis Investigative Site | Southington | Connecticut | 06489 | — |
| Novartis Investigative Site | Stamford | Connecticut | 06902-3628 | — |
| Novartis Investigative Site | Trumbull | Connecticut | 06611 | — |
| Novartis Investigative Site | Waterbury | Connecticut | 06708 | — |
| Novartis Investigative Site | Kissimmee | Florida | 34741 | — |
| Novartis Investigative Site | Loxahatchee Groves | Florida | 33470 | — |
| Novartis Investigative Site | New Port Richey | Florida | 34655 | — |
| Novartis Investigative Site | Augusta | Georgia | 30901 | — |
| Novartis Investigative Site | Lawrenceville | Georgia | 30046 | — |
| Novartis Investigative Site | Savannah | Georgia | 31405 | — |
| Novartis Investigative Site | Post Falls | Idaho | 83854 | — |
| Novartis Investigative Site | Chicago | Illinois | 60657 | — |
| Novartis Investigative Site | Oak Lawn | Illinois | 60453 | — |
| Novartis Investigative Site | Evansville | Indiana | 47713 | — |
| Novartis Investigative Site | Goshen | Indiana | 46526 | — |
| Novartis Investigative Site | Indianapolis | Indiana | 46237 | — |
| Novartis Investigative Site | Munster | Indiana | 46321 | — |
| Novartis Investigative Site | New Albany | Indiana | 47150 | — |
| Novartis Investigative Site | Towson | Maryland | 21204 | — |
| Novartis Investigative Site | Wheaton | Maryland | 20902 | — |
| Novartis Investigative Site | Bozeman | Montana | 59715 | — |
| Novartis Investigative Site | Grand Island | Nebraska | 68803 | — |
| Novartis Investigative Site | Kearney | Nebraska | 68845 | — |
| Novartis Investigative Site | Kearney | Nebraska | 68847 | — |
| Novartis Investigative Site | Denville | New Jersey | 07834 | — |
| Novartis Investigative Site | Parsippany | New Jersey | 07054 | — |
| Novartis Investigative Site | Cooperstown | New York | 13326 | — |
| Novartis Investigative Site | Greensboro | North Carolina | 27403 | — |
| Novartis Investigative Site | Canton | Ohio | 44718 | — |
| Novartis Investigative Site | Wooster | Ohio | 44691 | — |
| Novartis Investigative Site | Portland | Oregon | 97227 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15212-4772 | — |
| Novartis Investigative Site | Columbia | South Carolina | 29210 | — |
| Novartis Investigative Site | Memphis | Tennessee | 38120 | — |
| Novartis Investigative Site | Chesapeake | Virginia | 23320 | — |
| Novartis Investigative Site | Salem | Virginia | 24153 | — |
| Novartis Investigative Site | Bellevue | Washington | 98004 | — |
| Novartis Investigative Site | Kirkland | Washington | 98034 | — |
| Novartis Investigative Site | Mount Vernon | Washington | 98273 | — |
| Novartis Investigative Site | Seattle | Washington | 98109 | — |
| Novartis Investigative Site | Sequim | Washington | 98382 | — |
| Novartis Investigative Site | Tacoma | Washington | 98405 | — |
| Novartis Investigative Site | Wenatchee | Washington | 98801 | — |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 204 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00667251, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2025 · Synced Oct 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00667251 live on ClinicalTrials.gov.