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NCT00086957 · ClinicalTrials.gov registry record · Phase 1
Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 6
- Study locations
NCT00086957: Completed Phase 1 study of Breast Cancer, sponsored by City of Hope Medical Center.
NCT00086957 is a Phase 1 study of Breast Cancer that has completed, run by City of Hope Medical Center. The registered enrollment target is 31 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086957, a Phase 1 study of Breast Cancer, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 6
- Study locations
Study Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and trastuzumab with docetaxel may kill more tumor cells. PURPOSE: This phase I/II trial is studying the best dose of docetaxel when given together with gefitinib and trastuzumab in treating patients with metastatic breast cancer.
Primary Outcome
Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.
Conditions Studied
Interventions
- DRUG docetaxel
- BIOLOGICAL trastuzumab
- DRUG gefitinib
Study Locations (6)
California
- Tower Cancer Research Foundation - Beverly Hills
- City of Hope Comprehensive Cancer Center - Duarte
- Hematology Oncology Consultants-Hemet - Hemet
- Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- City of Hope Medical Group - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2004-01 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT00086957 record still lists
NCT00086957 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 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which docetaxel is the first listed.
NCT00086957 lists 6 locations in 1 state (California).
Frequently Asked Questions
What is clinical trial NCT00086957 about?
NCT00086957 is a clinical study titled "Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer". RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such...
What is the current status of trial NCT00086957?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2004-01. Estimated completion is 2015-08.
What conditions does trial NCT00086957 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00086957?
The interventions under investigation include: docetaxel (DRUG), trastuzumab (BIOLOGICAL), gefitinib (DRUG).
Who is sponsoring clinical trial NCT00086957?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00086957 being conducted?
This trial has 6 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00086957's enrollment target sits among peer trials
31 948th of 1224 higher than 271 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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