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COMPLETED Phase 3

Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes

NCT00003782 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.

Conditions Studied

Interventions

  • DRUG cyclophosphamide
  • DRUG docetaxel
  • DRUG doxorubicin

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • California Cancer Center — Fresno
  • Sutter Health Western Division Cancer Research Group — Greenbrae
  • Scripps Cancer Center at Scripps Clinic — La Jolla
  • Rebecca and John Moores UCSD Cancer Center — La Jolla
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center — Loma Linda
  • Pacific Shores Medical Group — Long Beach
  • CCOP - Bay Area Tumor Institute — Oakland
  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center — Orange
  • Comprehensive Cancer Centers of the Desert — Palm Springs
  • Stanford Cancer Center at Stanford University Medical Center — Palo Alto
  • Sutter Cancer Center — Sacramento
  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego — San Diego
  • Catholic Healthcare West - Westbay Region — San Francisco
  • CCOP - Santa Rosa Memorial Hospital — Santa Rosa
  • Kaiser Permanente Medical Center - Vallejo — Vallejo

Alabama

  • Comprehensive Cancer Institute — Huntsville

Alaska

  • Providence Alaska Medical Center — Anchorage

Arizona

  • CCOP - Western Regional, Arizona — Phoenix

Colorado

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center — Denver

Trial Details

FieldValue
Enrollment Target 5,351 participants
Start Date 1999-03
Est. Completion 2012-12
Phase Phase 3

Sponsor

NSABP Foundation

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00003782

The ClinicalTrials.gov registry entry for NCT00003782 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 5,351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 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: NCT00003782 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Alaska. 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 NCT00003782 about?

NCT00003782 is a clinical study titled "Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective ...

What is the current status of trial NCT00003782?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,351 participants. The study started on 1999-03. Estimated completion is 2012-12.

What conditions does trial NCT00003782 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00003782?

The interventions under investigation include: cyclophosphamide (DRUG), docetaxel (DRUG), doxorubicin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00003782?

This trial is sponsored by NSABP Foundation, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00003782 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial