Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
Public ClinicalTrials.gov record NCT00709761. 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
LPT 111111- A Single-arm, Multicenter Phase II Study to Evaluate The Combination of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel or ABRAXANE®) and Lapatinib (TYKERB®) in Women With No More Than One Prior Treatment for ErbB2 Overexpressing Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects were to receive treatment until disease progression or withdrawal from the study. The primary objective of this study was to evaluate overall tumor response rate of lapatinib in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel
Study identification
- NCT ID
- NCT00709761
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 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
- Jul 1, 2008
- Primary completion
- Jan 4, 2011
- Completion
- Jan 2, 2018
- Last update posted
- Mar 25, 2019
2008 – 2018
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | La Verne | California | 91750 | — |
| Novartis Investigative Site | Long Beach | California | 90813 | — |
| Novartis Investigative Site | Fort Myers | Florida | 33916 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30341 | — |
| Novartis Investigative Site | New York | New York | 10065 | — |
| Novartis Investigative Site | Rochester | New York | 14623 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | — |
| Novartis Investigative Site | Cleveland | Ohio | 44106 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | — |
| Novartis Investigative Site | Richmond | Virginia | 23230 | — |
| Novartis Investigative Site | Salem | Virginia | 24153 | — |
| Novartis Investigative Site | Everett | Washington | 98201 | — |
| Novartis Investigative Site | Tacoma | Washington | 98405 | — |
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 NCT00709761, 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 25, 2019 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00709761 live on ClinicalTrials.gov.