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

Sponsor:	Institute of Cancer Research, United Kingdom
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

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 Drug: leuprolide acetate Drug: methotrexate Drug: tamoxifen citrate Procedure: oophorectomy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Fluorouracil Methotrexate Tamoxifen Doxorubicin Doxorubicin hydrochloride Leuprolide Tamoxifen citrate Goserelin Leuprolide acetate Myocet

U.S. FDA Resources

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

Estimated Enrollment:	6000
Study Start Date:	June 1993

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

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

Locations

United Kingdom, England
Cancer Research Campaign Trials Unit-Birmingham (CRCTU)
Birmingham, England, United Kingdom, B15 2TT
United Kingdom, Scotland
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 - Surrey
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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. 2007 Apr 4;99(7):506-15.

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. 2007 Apr 4;99(7):516-25.

Perren TJ. Adjuvant therapy for operable breast cancer; more answers, new questions. Br J Cancer. 1995 Jun;71(6):1142-4. Review. No abstract available.

Brunt AM. The UKCCCR adjuvant breast cancer (ABC) trial. ABC Trial Steering Committee. Clin Oncol (R Coll Radiol). 1994;6(4):209-10. No abstract available.

Yarnold JR, Bliss JM, Brunt M, Earl H, Kaye S, Mason M, Mossman J, Perren T, Richards M. Management of breast cancer. Refer women to multidisciplinary breast clinics. BMJ. 1994 Mar 12;308(6930):714-5. No abstract available.

Bliss JM, Yarnold JR. Treatment of early breast cancer. Lancet. 1992 Apr 11;339(8798):936. No abstract available.

Study ID Numbers:	CDR0000063697, NCRI-ABC, CRC-TU-BR3010, SCTN-BR9401/BR9402, YRCO-ABC, EU-94029, UKCCCR-ABC
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002582 History of Changes
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:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Reproductive Control Agents
Cyclophosphamide
Selective Estrogen Receptor Modulators
Antibiotics, Antineoplastic
Estrogen Receptor Modulators
Neoplasms by Site

Leuprolide
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Breast Diseases
Estrogen Antagonists
Antineoplastic Agents, Hormonal
Skin Diseases
Goserelin
Breast Neoplasms
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on November 30, 2009