ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib
Public ClinicalTrials.gov record NCT00272987. 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, Double Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women With ErbB2 Overexpressing Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was originally designed as a Phase III randomized, double blind, placebo controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic breast cancer. The planned study was a two stage design with an initial open-label safety stage to be conducted in approximately 65 subjects followed by a randomized phase conducted in a further 700 subjects. The open-label part of the study sequentially enrolled three cohorts with patients receiving a different dose combination of paclitaxel, trastuzumab and lapatinib. Following poor recruitment rate in the open label stage, the randomized stage of the study was terminated, thus no subjects were enrolled into the randomization stage.
Study identification
- NCT ID
- NCT00272987
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 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
- Dec 12, 2005
- Primary completion
- Jul 30, 2009
- Completion
- Oct 20, 2019
- Last update posted
- Apr 27, 2023
2005 – 2019
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Roswell | Georgia | 30076 | — |
| Novartis Investigative Site | Joliet | Illinois | 60435 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202 | — |
| Novartis Investigative Site | Jackson | Mississippi | 39202 | — |
| Novartis Investigative Site | Voorhees Township | New Jersey | 08043 | — |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27103 | — |
| Novartis Investigative Site | Canton | Ohio | 44718 | — |
| Novartis Investigative Site | Columbus | Ohio | 43219 | — |
| Novartis Investigative Site | Middletown | Ohio | 45042 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29406 | — |
| Novartis Investigative Site | Amarillo | Texas | 79106 | — |
| Novartis Investigative Site | Houston | Texas | 77030-4009 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | Richmond | Virginia | 23230 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00272987, 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 Apr 27, 2023 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00272987 live on ClinicalTrials.gov.