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Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Scottish Cancer Therapy Network
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002581
  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. Combining combination chemotherapy with hormone therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without combination chemotherapy in treating postmenopausal women with stage I or stage II breast cancer that can be surgically removed.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: fluorouracil
Drug: methotrexate
Drug: tamoxifen citrate
Procedure: conventional surgery
Procedure: radiation therapy
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cyclophosphamide Methotrexate Fluorouracil Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: PROTOCOL FOR THE SCOTTISH POSTMENOPAUSAL CHEMO-ENDOCRINE TRIAL

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

Estimated Enrollment: 1000
Study Start Date: June 1993
Detailed Description:

OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without cyclophosphamide, methotrexate, and fluorouracil (CMF) in postmenopausal women with stage I-IIIA, unilateral, invasive breast cancer.

OUTLINE: This is a randomized study, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after completion of chemotherapy for patients randomized to arm II. Patients are randomized to 1 of 2 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1 (CMF). Chemotherapy continues every 3 weeks for 6 courses. Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven unilateral, invasive breast cancer Stage T0-3, N0-1, M0 No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No carcinoma in situ alone, including Paget's disease of the nipple without underlying invasion No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No history of pure carcinoma in situ in either breast Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Postmenopausal, defined by 1 of the following criteria: Last menstrual period more than 1 year before initial surgery Any age with prior bilateral oophorectomy (for nonmalignant reason) Age 50 and over with prior hysterectomy (for nonmalignant reason) without oophorectomy If at variance with the above definitions, hormonal assays in postmenopausal range take precedence Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other serious illness No other prior invasive malignancy except adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002581

Locations
United Kingdom
Ayr Hospital
Ayr, United Kingdom, KA6 6DX
Falkirk Royal Infirmary
Falkirk, United Kingdom, FK1 5RE
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
Sponsors and Collaborators
Scottish Cancer Therapy Network
Investigators
Study Chair: W.D. George, MD, MS, FRCS University of Glasgow
  More Information

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

Study ID Numbers: CDR0000063696, SCTN-BR9402, EU-94003, UKCCCR-ABC/BR9402
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002581  
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

Study placed in the following topic categories:
Folic Acid
Skin Diseases
Fluorouracil
Citric Acid
Methotrexate
Breast Neoplasms
Cyclophosphamide
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009