Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
NCT00513292 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00513292 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00513292?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.