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Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer Clinical research trials and Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer  Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
For Condition: stage 1 breast cancer,stage 2 breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): Scottish Cancer Therapy Network ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
W.D.George, Study Chair, Scottish Cancer Therapy Network
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
University of Glasgow
Glasgow, Scotland, G61 1BD
United Kingdom
Ayr Hospital
Ayr, , KA6 6DX
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
United Kingdom
Falkirk Royal Infirmary
Falkirk, , FK1 5RE
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Royal Alexandra Hospital
Paisley, Scotland,
United Kingdom
Additional Information:
Study ID Numbers: CDR0000063696; SCTN-BR9402,EU-94003,UKCCCR-ABC/BR9402
Study Start Date: June 1993
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002581
Other Stage 3a Breast Cancer Studies:
1. Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
2. Triptorelin Compared With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
3. Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
4. Cryosurgery in Treating Women With Breast Lesions
5. Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
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