SWOG-8814 Tamoxifen With or Without Combination Chemotherapy in Postmenopausal Women Who Have Undergone Surgery for Breast Cancer

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen alone is more effective in treating breast cancer than giving tamoxifen together with chemotherapy or after chemotherapy.

PURPOSE: This randomized phase III trial is studying giving tamoxifen with or without combination chemotherapy to compare how well they work in treating postmenopausal women who have undergone surgery for breast cancer.

Conditions

• Breast Cancer

Interventions

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

endocrine therapy

DRUG

endocrine-modulating drug therapy

DRUG

fluorouracil

DRUG

tamoxifen citrate

RADIATION

brachytherapy

RADIATION

low-LET electron therapy

RADIATION

low-LET photon therapy

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• North Central Cancer Treatment Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• NCIC Clinical Trials Group

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Kathy S. Albain, MD · Loyola University

• Charles D. Cobau, MD · Flower Hospital Cancer Center

• James N. Ingle, MD · Mayo Clinic

• Ellis G. Levine, MD · Roswell Park Cancer Institute

• Kathleen I. Pritchard, MD · Toronto Sunnybrook Regional Cancer Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1989-05-31

Primary Completion

2005-08-31

Completion

2010-03-31