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NCT00041119 · ClinicalTrials.gov registry record · Phase 3

Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer

A Phase 3 study of Breast Cancer, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
3,871
Enrollment target
20
Study locations

NCT00041119 is a Phase 3 study of Breast Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 3,871 participants, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT00041119, a Phase 3 study of Breast Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
3,871 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer

Conditions Studied

Interventions

  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • DRUG doxorubicin hydrochloride
  • DRUG AC regimen

Study Locations (20)

California

  • Alta Bates Summit Comprehensive Cancer Center - Berkeley
  • Peninsula Medical Center - Burlingame
  • East Bay Radiation Oncology Center - Castro Valley
  • Valley Medical Oncology Consultants - Castro Valley - Castro Valley
  • Valley Medical Oncology - Fremont
  • Washington Township Hospital - Fremont
  • California Cancer Center - Woodward Park Office - Fresno
  • Cancer Care Associates - Fresno
  • Marin Cancer Institute at Marin General Hospital - Greenbrae
  • Rebecca and John Moores UCSD Cancer Center - La Jolla
  • USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
  • Contra Costa Regional Medical Center - Martinez
  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP - Marysville
  • Memorial Medical Center - Modesto

Alabama

  • Regional Medical Center - Anniston
  • UAB Comprehensive Cancer Center - Birmingham
  • Providence Cancer Center at Providence Hospital - Mobile

Alaska

  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital - Fairbanks

Arizona

  • Mayo Clinic Scottsdale - Scottsdale

Arkansas

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center - Fort Smith

Trial Details

FieldValue
Enrollment Target 3,871 participants
Start Date 2002-05
Est. Completion 2014-06
Phase Phase 3

What the Registry Record Tells You About NCT00041119

The ClinicalTrials.gov registry entry for NCT00041119 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,871 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (38% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which cyclophosphamide is the first listed.

NCT00041119 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Alaska.

Frequently Asked Questions

What is clinical trial NCT00041119 about?

NCT00041119 is a clinical study titled "Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer". This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer w...

What is the current status of trial NCT00041119?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,871 participants. The study started on 2002-05. Estimated completion is 2014-06.

What conditions does trial NCT00041119 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00041119?

The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), doxorubicin hydrochloride (DRUG), AC regimen (DRUG).

Who is sponsoring clinical trial NCT00041119?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00041119 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.