Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.

Conditions

• Breast Cancer

Interventions

DRUG

CMF regimen

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

fluorouracil

DRUG

goserelin acetate

DRUG

leuprolide acetate

DRUG

methotrexate

DRUG

tamoxifen citrate

PROCEDURE

oophorectomy

RADIATION

radiation therapy

Sponsors & Collaborators

• Cancer Research Campaign Clinical Trials Centre

  collaborator OTHER

• Scottish Cancer Therapy Network

  collaborator OTHER

• Yorkshire Regional Clinical Trials Research Unit

  collaborator OTHER

• Institute of Cancer Research, United Kingdom

  lead OTHER

Principal Investigators

• John R. Yarnold, MD, FRCR · Royal Marsden NHS Foundation Trust

• Helena Earl, MBBS, PhD, FRCP · Cancer Research Campaign Clinical Trials Centre

• Stanley B. Kaye, MD, FRCP · University of Glasgow

• Tim J. Perren, MD · Leeds Cancer Centre at St. James's University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1993-06-30

Completion

2007-04-30

Countries

• United Kingdom

Study Locations