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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5351

Last updated 2024-03-21

Study results available
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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

Interventions

DRUG

cyclophosphamide

Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles

DRUG

docetaxel

Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles

DRUG

doxorubicin

Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2008-12-31
Completion
2012-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003782 on ClinicalTrials.gov