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

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 if high-dose combination chemotherapy plus peripheral stem cell transplantation is more effective than standard combination chemotherapy for breast cancer.

PURPOSE: Randomized phase III trial to compare high-dose combination chemotherapy plus peripheral stem cell transplantation with standard combination chemotherapy in treating women with stage II or stage III breast cancer.

Conditions

• Breast Cancer

Interventions

BIOLOGICAL

filgrastim

Filgrastim 10 mg/kg/d sc for 6 days after randomization.

DRUG

CMF regimen

Cyclophosphamide 100 mg/m2 orally days 1 - 14, methotrexate 40 mg/m2 iv days 1 and 8, 5-fluorouracil 600 mg/m2 iv days 1 and 8. Repeat every 28 days.

DRUG

cyclophosphamide

For high-dose EC arm: cyclophosphamide 4 gm/m2 iv as 4 divided doses. For standard chemotherapy arm: cyclophosphamide 600 mg/m2 iv day 1 of 21-day EC cycles, and cyclophosphamide 100 mg/m2 orally on days 1-14 of 28-day CMF cycles.

DRUG

doxorubicin hydrochloride

Doxorubicin 60 mg/m2 iv on day 1 of 21-day cycles of AC.

DRUG

epirubicin hydrochloride

Epirubicin 90 mg/m2 iv on day 1 of 21-day cycles of EC.

DRUG

fluorouracil

5-fluorouracil 600 mg/m2 iv days 1 and 8 of 28-day cycles of CMF.

DRUG

mesna

MESNA (7.2 gm/m2) on days 2 and 3 of 21-day cycles of dose-intensive EC.

DRUG

methotrexate

Methotrexate 40 mg/m2 iv on days 1 and 8 of 28-day cycles of CMF.

DRUG

tamoxifen citrate

Tamoxifen 20mg daily for 5 years or until relapse.

PROCEDURE

peripheral blood stem cell transplantation

Peripheral blood progenitor cells (PBPC) infusion on day 5 of each 21-day cycle of dose-intensive EC.

RADIATION

low-LET electron therapy

Radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.

RADIATION

low-LET photon therapy

radiation therapy to the conserved breast is mandatory, to be carried out according to the prospectively defined guidelines of each participating institution; either after all chemotherapy or integrated into CMF as agreed per institution. Radiotherapy to the chest wall following mastectomy is optional according to the prospectively defined guidelines of each participating institution.

Sponsors & Collaborators

• ETOP IBCSG Partners Foundation

  lead NETWORK

Principal Investigators

• Russell Basser, MD · Melbourne Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1996-06-30

Primary Completion

2011-08-31

Completion

2011-12-31

Countries

• Australia
• Switzerland

Study Locations