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NCT00513292 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
A Phase 3 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT00513292 is a Phase 3 study of Stage II Breast Cancer and Stage IIIA Breast Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 280 participants, below the 310-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00513292, a Phase 3 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Epirubicin Hydrochloride
Study Locations (20)
California
- Eden Hospital Medical Center - Castro Valley
- Marin Cancer Care Inc - Greenbrae
- Saint Rose Hospital - Hayward
- Valley Care Health System - Pleasanton - Pleasanton
- Valley Medical Oncology Consultants - Pleasanton
Florida
- Morton Plant Hospital - Clearwater
- Broward Health Medical Center - Fort Lauderdale
- Lakeland Regional Cancer Center - Lakeland
Indiana
- Saint Francis Hospital and Health Centers - Beech Grove
- Franciscan Saint Francis Health-Indianapolis - Indianapolis
- Reid Hospital and Health Care Services - Richmond
Iowa
- Siouxland Regional Cancer Center - Sioux City
- Mercy Medical Center-Sioux City - Sioux City
- Saint Luke's Regional Medical Center - Sioux City
Kansas
- Cancer Center of Kansas - Chanute - Chanute
- Cancer Center of Kansas - Dodge City - Dodge City
- Cancer Center of Kansas - El Dorado - El Dorado
Alabama
- University of South Alabama Mitchell Cancer Institute - Mobile
Georgia
- Northeast Georgia Medical Center - Gainesville
Illinois
- Presence Resurrection Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2007-07 |
| Est. Completion | 2013-02-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00513292
The ClinicalTrials.gov registry entry for NCT00513292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 310-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (10% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00513292 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00513292 about?
NCT00513292 is a clinical study titled "Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery". This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzu...
What is the current status of trial NCT00513292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2007-07. Estimated completion is 2013-02-21.
What conditions does trial NCT00513292 study?
This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, HER2/Neu Positive.
What interventions are being tested in trial NCT00513292?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Therapeutic Conventional Surgery (PROCEDURE), Epirubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00513292?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00513292 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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