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Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

NCT00002755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-11-06

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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard cyclophosphamide, methotrexate, and fluorouracil with that of high-dose combination chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or stage IIIA breast cancer.

Conditions

Interventions

BIOLOGICAL

filgrastim

DRUG

CMF regimen

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

fluorouracil

DRUG

methotrexate

DRUG

tamoxifen citrate

DRUG

thiotepa

PROCEDURE

autologous bone marrow transplantation

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

low-LET cobalt-60 gamma ray therapy

RADIATION

low-LET electron therapy

RADIATION

low-LET photon therapy

Sponsors & Collaborators

  • Scottish Cancer Therapy Network

    lead OTHER

Principal Investigators

  • Robert C.F. Leonard, MD, BS, MB · Edinburgh Cancer Centre at Western General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-11-30
Completion
1999-06-30

Countries

  • Ireland
  • United Kingdom

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 NCT00002755 on ClinicalTrials.gov