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Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer Clinical research trials and Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer. Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer  Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
For Condition: stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): British Association of Surgical Oncology: Breast Group ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. Combining radiation therapy and tamoxifen with surgery may kill more tumor cells. It is not yet known which treatment regimen is most effective for stage I breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of four different treatment regimens in treating women who have stage I breast cancer.
Details: OBJECTIVES: I. Compare the effectiveness of wide local excision alone versus wide local excision followed by radiotherapy with or without tamoxifen versus wide local excision plus tamoxifen in patients with stage I breast cancer. II. Assess local occurrence in the treated breast, regional recurrence, distant recurrence, death from breast cancer, and occurrence of cancer in the opposite breast in these patients when treated with one of these regimens. PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of four treatment arms. All patients undergo wide local excision of the tumor and axillary node dissection. Arm I: Patients undergo surgery only. Arm II: Patients undergo surgery followed by 25-35 radiotherapy treatments. Arm III: Patients undergo surgery plus oral tamoxifen daily for 5 years. Arm IV: Patients undergo surgery followed by 25-35 radiotherapy treatments and oral tamoxifen daily for five years. Patients are followed every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 1200 patients (300 per treatment arm) 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 confirmed unilateral stage I invasive breast cancer; No more than 1 tumor and no greater than 2 cm; Grade 1 tumor of any histological type OR; No special type OR Mixed type allowed; No lymph node involvement; No in situ carcinoma only or ductal carcinoma in situ with microinvasion; No vascular invasion; No Paget's disease of the nipple; Well differentiated special type of primary mammary carcinoma including: Tubular; Tubular/cribriform Cribriform; Papillary; Mucoid; No lobular, medullary, or other rarer types of mammary carcinomas including: Adenoid cystic; Carcinoid Secretory; Spindle cell; Apocrine - No distant metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - No other concurrent adjuvant systemic therapy --Patient Characteristics-- - Age: Under 70 - Sex: Female - Menopausal status: Not specified - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Not pregnant or nursing; No other systemic disease that may preclude study; No other prior malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
R.W.Blamey, Study Chair, British Association of Surgical Oncology: Breast Group
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068043; EU-20019,BASO-BREAST-BASO-II
Study Start Date: January 1992
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006030
Other Stage 1 Breast Cancer Studies:
1. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
2. Exemestane Compared With Anastrozole, With or Without Celecoxib, in Treating Postmenopausal Women After Surgery for Primary Breast Cancer
3. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
4. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
5. Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other England Clinical Trials
Other Nottingham Clinical Trials
Comparison of Four Different Treatment Regimens in Treating Women With Stage I Breast Cancer
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