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Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

NCT00024102 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 633

Last updated 2016-08-12

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. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

Conditions

Interventions

DRUG

Standard Treatment

Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 \& 8 and 5-FU 600 mg/sq m IV push d 1 \& 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles

DRUG

capecitabine

2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Hyman B. Muss, MD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2008-05-31
Completion
2012-11-30

Countries

  • United States
  • Canada
  • Peru

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 NCT00024102 on ClinicalTrials.gov