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Sponsored by: |
Scottish Cancer Therapy Network |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002579 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate Drug: tamoxifen citrate Procedure: conventional surgery Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | PROTOCOL FOR THE SCOTTISH CHEMO-ENDOCRINE TRIAL D |
Estimated Enrollment: | 2000 |
Study Start Date: | March 1993 |
OBJECTIVES: I. Assess the disease-free and overall survival produced by adjuvant tamoxifen given after postoperative chemotherapy with cyclophosphamide/methotrexate/fluorouracil (CMF) vs. adjuvant CMF alone in women with primary breast cancer.
OUTLINE: This is a randomized study. Patients are stratified by age and by participating institution. All patients undergo surgical resection with local radiation therapy, as appropriate. Within 4 weeks of surgery, patients receive cyclophosphamide, methotrexate, and fluorouracil (CMF) every 3 weeks for 6 courses. Radiotherapy is given within 4 weeks of completion of CMF. Before beginning the last course of CMF, patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy. Patients are followed every 6 months for 5 years, then yearly. Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms.
PROJECTED ACCRUAL: Approximately 2,000 patients will be required. Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 study.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer with palpable, unilateral, invasive disease Bilateral mammography required within 1 year prior to randomization TNM Stage T1-3, N0-1, M0 disease for which adjuvant chemotherapy is considered an essential part of initial therapy No prior pure in situ carcinoma in either breast No concurrent in situ carcinoma only No Paget's disease of the nipple without underlying invasion No evidence of distant disease, e.g.: No ipsilateral supraclavicular node enlargement unless proven benign Hormone receptor status: Any status
PATIENT CHARACTERISTICS: Age: Not specified Sex: Women only Menopausal status: Pre- or postmenopausal Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious unrelated illness No prior invasive malignancy at any other site except adequately treated nonmelanomatous skin cancer No pregnant or nursing women Adequate contraception required
PRIOR CONCURRENT THERAPY: No prior tamoxifen and not currently receiving tamoxifen
United Kingdom | |
Ayr Hospital | |
Ayr, United Kingdom, KA6 6DX | |
Falkirk Royal Infirmary | |
Falkirk, United Kingdom, FK1 5RE | |
United Kingdom, England | |
Leicester Royal Infirmary NHS Trust | |
Leicester, England, United Kingdom, LE1 5WW | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Beatson Oncology Centre | |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
Raigmore Hospital | |
Inverness, Scotland, United Kingdom, 1V2 3UJ | |
Royal Alexandra Hospital | |
Paisley, Scotland, United Kingdom | |
University of Glasgow | |
Glasgow, Scotland, United Kingdom, G61 1BD | |
Ninewells Hospital and Medical School | |
Dundee, Scotland, United Kingdom, DD1 9SY |
Study Chair: | W.D. George, MD, MS, FRCS | University of Glasgow |
Study ID Numbers: | CDR0000063694, SCTN-BR9403, EU-94004 |
Study First Received: | November 1, 1999 |
Last Updated: | January 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00002579 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Folic Acid Skin Diseases Fluorouracil Citric Acid Methotrexate |
Breast Neoplasms Cyclophosphamide Tamoxifen Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Therapeutic Uses Abortifacient Agents |
Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Estrogen Antagonists Antineoplastic Agents, Hormonal Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |