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Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer

NCT00087178 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2722

Last updated 2022-08-11

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide, and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer.

PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes.

Conditions

Interventions

DRUG

cyclophosphamide

Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

DRUG

adriamycin

adriamycin 60 mg/m2 IV every 21 days for 4 cycles

DRUG

epirubicin

epirubicin 100 mg/m2 IV every 21 days for 6 cycles

DRUG

fluorouracil

fluorouracil 500 mg/m2 IV every 21 days for 6 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
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2014-03-31
Completion
2016-05-31

Countries

  • United States
  • Canada
  • Puerto Rico

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 NCT00087178 on ClinicalTrials.gov