Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects
Public ClinicalTrials.gov record NCT00709618. 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 Phase II, Single-Arm, Multi-Center Study Evaluating the Combination of Vinorelbine and Lapatinib in Women With ErbB2 Overexpressing Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, single-arm, multi-center, Phase II study to determine the activity of vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study. Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease progression or withdrawal from the study. The primary objective of this study is to evaluate overall tumor response rate of lapatinib in combination with vinorelbine. Secondary objectives include progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments will be performed at 4, 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib, Vinorelbine
Study identification
- NCT ID
- NCT00709618
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 44 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
- Jun 2008 (Type not available)
- Primary completion
- May 2012 (Actual)
- Completion
- May 2012 (Actual)
- Last update posted
- Jul 14, 2014
2008 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Muscle Shoals | Alabama | 35661 | — |
| GSK Investigational Site | Tucson | Arizona | 85715 | — |
| GSK Investigational Site | Sacramento | California | 95817 | — |
| GSK Investigational Site | Jacksonville | Florida | 32204 | — |
| GSK Investigational Site | Plantation | Florida | 33324 | — |
| GSK Investigational Site | Augusta | Georgia | 30901 | — |
| GSK Investigational Site | Cedar Rapids | Iowa | 52402 | — |
| GSK Investigational Site | Baltimore | Maryland | 21237 | — |
| GSK Investigational Site | Bethesda | Maryland | 20817 | — |
| GSK Investigational Site | Jackson | Mississippi | 39202 | — |
| GSK Investigational Site | Kansas City | Missouri | 64118 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Omaha | Nebraska | 68114 | — |
| GSK Investigational Site | New York | New York | 10065 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27403 | — |
| GSK Investigational Site | Columbus | Ohio | 43219 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74136 | — |
| GSK Investigational Site | Eugene | Oregon | 97401 | — |
| GSK Investigational Site | Portland | Oregon | 97239-3098 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19106 | — |
| GSK Investigational Site | Memphis | Tennessee | 38120 | — |
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 NCT00709618, 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 Jul 14, 2014 · 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 NCT00709618 live on ClinicalTrials.gov.