Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.
Public ClinicalTrials.gov record NCT00524303. 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
Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With ErbB2- (HER2/Neu-) Overexpressing Invasive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.
Study identification
- NCT ID
- NCT00524303
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
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
- Aug 2007 (Type not available)
- Primary completion
- Oct 2010 (Actual)
- Completion
- Aug 2015 (Actual)
- Last update posted
- Nov 11, 2016
2007 – 2015
United States locations
- U.S. sites
- 23
- U.S. states
- 9
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Los Angeles | California | 90057 | — |
| GSK Investigational Site | Denver | Colorado | 80220 | — |
| GSK Investigational Site | Hudson | Florida | 34667 | — |
| GSK Investigational Site | Miami | Florida | 33176 | — |
| GSK Investigational Site | Pembroke Pines | Florida | 33028 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46219 | — |
| GSK Investigational Site | Henderson | Nevada | 89052 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Austin | Texas | 78731 | — |
| GSK Investigational Site | Beaumont | Texas | 77702-1449 | — |
| GSK Investigational Site | Bedford | Texas | 76022 | — |
| GSK Investigational Site | Dallas | Texas | 75231 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Dallas | Texas | 75320-2510 | — |
| GSK Investigational Site | El Paso | Texas | 79915 | — |
| GSK Investigational Site | Houston | Texas | 77024 | — |
| GSK Investigational Site | Lewisville | Texas | 75067 | — |
| GSK Investigational Site | Sugar Land | Texas | 77479 | — |
| GSK Investigational Site | Tyler | Texas | 75702 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Seattle | Washington | 98117 | — |
| GSK Investigational Site | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00524303, 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 Nov 11, 2016 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00524303 live on ClinicalTrials.gov.