S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

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 the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.

Conditions

• Breast Cancer

Interventions

BIOLOGICAL

filgrastim

DRUG

carboplatin

DRUG

carmustine

DRUG

cisplatin

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

paclitaxel

DRUG

tamoxifen citrate

DRUG

thiotepa

PROCEDURE

autologous bone marrow transplantation

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Scott I. Bearman, MD · University of Colorado, Denver

• Antonio C. Wolff, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Clifford A. Hudis, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1996-07-31

Primary Completion

2004-02-29

Completion

2004-02-29

Countries

• United States

Study Locations