Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.
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 |
What the finished NCT00513292 record still lists
NCT00513292 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 310-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (10% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Stage II Breast Cancer
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 NCT00513292's enrollment target sits among peer trials
280 7th of 30 higher than 24 of 30 other Stage II Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage II 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
ACTIVE NOT RECRUITING · Phase 3
-
Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
ACTIVE NOT RECRUITING · Phase 3
-
Comparison of Axillary Lymph Node Dissection with Axillary Radiation for Patients with Node-Positive Breast Cancer Treated with Chemotherapy
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.
RECRUITING · NA
-
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04084730 · 280 participants · Phase 2
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
- NCT04518657 · 280 participants · NA
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
- NCT04634916 · 280 participants · NA
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
- NCT04829617 · 280 participants · NA
Promoting Well-being and Health in Heart Failure
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia