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Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer Clinical research trials and Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer clinical trial. Human subjects often get the best healthcare possible for their Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer  Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal 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. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I or stage II breast cancer that can be removed by surgery.
Details: OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without ovarian suppression and/or cyclophosphamide, methotrexate, and fluorouracil (CMF) in premenopausal women with stage I-IIIA, unilateral, invasive breast cancer. PROTOCOL OUTLINE: This is a randomized, 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 after surgery for patients randomized to arm I or III and within 4 weeks after completion of chemotherapy for patients randomized to arm II or IV. Patients are randomized to 1 of 4 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 in the absence of disease progression or unacceptable toxicity. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV (CMF) on day 1. Chemotherapy continues every 3 weeks for 6 courses. Arm III: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and 1 of 3 ovarian suppression regimens, preferably regimen A. Regimen B is the preferred alternative to regimen A. Regimen A: Patients undergo oophorectomy. Regimen B: Patients undergo radiation-induced menopause comprising radiotherapy to the pelvis on days 1-4. Regimen C: Beginning 4 weeks after surgery, patients receive goserelin subcutaneously (SC) or leuprolide SC or intramuscularly on day 1. Treatment continues every 4 weeks for 2 years. Arm IV: Patients receive tamoxifen as in arm I and CMF as in arm II followed within 4 weeks by ovarian suppression as in arm III. 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 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: Premenopausal, defined by 1 of the following criteria: Last menstrual period less than 1 year before surgery; Under age 50 with prior hysterectomy (for nonmalignant reason) without bilateral oophorectomy; Under age 50 and on continuous oral contraception If at variance with the above definitions, hormonal assays in the premenopausal range take precedence - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: Not pregnant or nursing; 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
Ayr Hospital
Ayr, , KA6 6DX
United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
United Kingdom
Royal Alexandra Hospital
Paisley, Scotland,
United Kingdom
University of Glasgow
Glasgow, Scotland, G61 1BD
United Kingdom
University Hospitals of Leicester
Leicester, England, LE1 5WW
United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Falkirk Royal Infirmary
Falkirk, , FK1 5RE
United Kingdom
Additional Information:
Study ID Numbers: CDR0000063695; SCTN-BR9401,EU-94002,UKCCCR-ABC/BR9401
Study Start Date: June 1993
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002580
Other Stage 1 Breast Cancer Studies:
1. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
2. Erlotinib in Treating Women With Locally Advanced or Metastatic Breast Cancer
3. Neoadjuvant Epirubicin, Cyclophosphamide, and Paclitaxel With or Without Gemcitabine in Treating Women With Early Breast Cancer
4. Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
5. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Clinical Trials
Other Falkirk Clinical Trials
Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
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