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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer

NCT00003972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2010-04-02

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage II or stage IIIA breast cancer.

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

sargramostim

DRUG

busulfan

DRUG

carboplatin

DRUG

cyclophosphamide

DRUG

melphalan

DRUG

paclitaxel

DRUG

tamoxifen citrate

DRUG

thiotepa

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • William I. Bensinger, MD · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-07-31
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • United States

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 NCT00003972 on ClinicalTrials.gov