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| 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 |
|---|---|
| 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 |
| Estimated Enrollment: | 6000 |
| Study Start Date: | June 1993 |
OBJECTIVES:
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).
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
No prior malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |
| 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
| 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 |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Antimetabolites Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Folate Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators Hormones Vitamin B9 Anti-Bacterial Agents Estrogen Receptor Modulators Leuprolide Methotrexate Alkylating Agents |
Breast Diseases Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Citric Acid Adjuvants, Immunologic Goserelin Breast Neoplasms Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Tamoxifen Doxorubicin Folic Acid |
|
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 Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
