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NCT00367471 · ClinicalTrials.gov registry record · Phase 1
Combination Of Lapatinib With Carboplatin, Paclitaxel, and With or Without Trastuzumab In Metastatic Breast Cancer.
A Phase 1 study of Neoplasms, Breast, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 3
- Study locations
NCT00367471: Completed Phase 1 study of Neoplasms, Breast, sponsored by Novartis Pharmaceuticals.
NCT00367471 is a Phase 1 study of Neoplasms, Breast that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants, below the 1,064-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00367471, a Phase 1 study of Neoplasms, Breast, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to determine the optimally-tolerated regimens (OTR) for lapatinib in combination with paclitaxel, carboplatin with and without trastuzumab in patients with metastatic breast cancer.
Primary Outcome
* The OTR for Treatment Group A (lapatinib, paclitaxel, carboplatin, and trastuzumab) will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle. * The OTR for Treatment Group B (lapatinib, paclitaxel, carboplatin) will be defined as the maximum dose level at which no more than one subject out of six experiences a DLT after completing one treatment cycle. * Adverse events and changes from
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG trastuzumab
- DRUG paclitaxel
- DRUG lapatinib
Study Locations (3)
California
- Novartis Investigative Site - La Jolla
Indiana
- Novartis Investigative Site - Indianapolis
North Carolina
- Novartis Investigative Site - Greensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-12-07 |
| Est. Completion | 2019-09-12 |
| Phase | Phase 1 |
What the finished NCT00367471 record still lists
NCT00367471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,064-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 4 interventions - of which carboplatin is the first listed.
NCT00367471 reports a single indexed study location in California, Indiana, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00367471 about?
NCT00367471 is a clinical study titled "Combination Of Lapatinib With Carboplatin, Paclitaxel, and With or Without Trastuzumab In Metastatic Breast Cancer.". The purpose of this study is to determine the optimally-tolerated regimens (OTR) for lapatinib in combination with paclitaxel, carboplatin with and without trastuzumab in patients with metastatic breast cancer.
What is the current status of trial NCT00367471?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2006-12-07. Estimated completion is 2019-09-12.
What conditions does trial NCT00367471 study?
This clinical trial studies the following conditions: Neoplasms, Breast.
What interventions are being tested in trial NCT00367471?
The interventions under investigation include: carboplatin (DRUG), trastuzumab (DRUG), paclitaxel (DRUG), lapatinib (DRUG).
Who is sponsoring clinical trial NCT00367471?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00367471 being conducted?
This trial has 3 study locations across California, Indiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms, Breast
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00367471's enrollment target sits among peer trials
31 10th of 9 the lowest of 9 other Neoplasms, Breast trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms, Breast trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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