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

This study has been completed.
Sponsor:
Collaborators:
Cancer Research Campaign Clinical Trials Centre
Scottish Cancer Therapy Network
Yorkshire Regional Clinical Trials Research Unit
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002582
First received: November 1, 1999
Last updated: August 1, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 6000
Study Start Date: June 1993
Study Completion Date: April 2007
Detailed Description:

OBJECTIVES:

  • Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option.

Postmenopausal women are randomized to the first or second groups.

Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as follows: among all four groups; for chemotherapy alone (first versus second group); for ovarian suppression alone (first versus third group); for ovarian suppression with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy with nonrandomized assignment to ovarian suppression (second versus fourth group).

  • First group: Patients receive tamoxifen by mouth every day for 5 years.
  • Second group: Patients receive tamoxifen plus cyclophosphamide, methotrexate, fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6 courses; AC is given every 3 weeks for 4 courses.
  • Third group: Patients receive tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin.
  • Fourth group: Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC.

Patients are followed for overall and relapse-free survival.

PROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal) will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate

    • Stage I, II, or IIIA
    • Pathologically positive or negative nodes
    • Any size primary tumor
  • No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Pre-, peri-, or postmenopausal

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No prior malignancy except:

    • Basal cell carcinoma
    • Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior systemic treatment for breast cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002582

Locations
United Kingdom
Cancer Research Campaign Trials Unit-Birmingham (CRCTU)
Birmingham, England, United Kingdom, B15 2TT
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research Campaign Clinical Trials Centre
Scottish Cancer Therapy Network
Yorkshire Regional Clinical Trials Research Unit
Investigators
Study Chair: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
Study Chair: Helena Earl, MBBS, PhD, FRCP Cancer Research Campaign Clinical Trials Centre
Study Chair: Stanley B. Kaye, MD, FRCP University of Glasgow
Study Chair: Tim J. Perren, MD Leeds Cancer Centre at St. James's University Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002582     History of Changes
Other Study ID Numbers: NCRI-ABC, CDR0000063697, CRC-TU-BR3010, SCTN-BR9401/BR9402, YRCO-ABC, EU-94029, UKCCCR-ABC
Study First Received: November 1, 1999
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Methotrexate
Liposomal doxorubicin
Doxorubicin
Tamoxifen
Leuprolide
Goserelin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on August 28, 2014