Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCRI-ABC CRC-TU-BR3010, SCTN-BR9401/BR9402, YRCO-ABC, EU-94029, UKCCCR-ABC, NCT00002582

Objectives

1. 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.

Entry 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

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

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

Expected Enrollment

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

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.

Adjuvant Breast Cancer Trials Collaborative Group.: Polychemotherapy for early breast cancer: results from the international adjuvant breast cancer chemotherapy randomized trial. J Natl Cancer Inst 99 (7): 506-15, 2007.[PUBMED Abstract]

Adjuvant Breast Cancer Trials Collaborative Group.: Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial. J Natl Cancer Inst 99 (7): 516-25, 2007.[PUBMED Abstract]

Perren TJ: Adjuvant therapy for operable breast cancer; more answers, new questions. Br J Cancer 71 (6): 1142-4, 1995.[PUBMED Abstract]

Brunt AM: The UKCCCR adjuvant breast cancer (ABC) trial. ABC Trial Steering Committee. Clin Oncol (R Coll Radiol) 6 (4): 209-10, 1994.[PUBMED Abstract]

Yarnold JR, Bliss JM, Brunt M, et al.: Management of breast cancer. Refer women to multidisciplinary breast clinics. BMJ 308 (6930): 714-5, 1994.[PUBMED Abstract]

Bliss JM, Yarnold JR: Treatment of early breast cancer. Lancet 339 (8798): 936, 1992.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

National Cancer Research Institute

John Yarnold, MD, FRCR, Protocol chair		Ph: 44-20-8661-3388

Cancer Research UK Clinical Trials Unit - Birmingham

Helena Earl, MBBS, PhD, FRCP, Protocol chair(Contact information may not be current)		Ph: 44-121-414-3787

Scottish Cancer Therapy Network

Stanley Kaye, MD, FRCP, Protocol chair(Contact information may not be current)		Ph: 44-141-211-2824 Email: s.b.kay@beatson.gla.ac.uk

Yorkshire Regional Clinical Trials & Research Unit

Tim Perren, MD, Protocol chair		Ph: 44-113-206-4670 Email: t.j.perren@leeds.ac.uk

Registry Information
Official Title		UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL
Trial Start Date		1993-06-01
Registered in ClinicalTrials.gov		NCT00002582
Date Submitted to PDQ		1993-06-01
Information Last Verified		2007-05-31