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Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA 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, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Clinical research trials and Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA 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, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer. Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA 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, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA 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, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer  Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): United Kingdom Coordinating Committee on Cancer Research , Cancer Research Campaign Clinical Trials Centre,Scottish Cancer Therapy Network,Yorkshire Regional Clinical Trials Research Unit
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. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
Details: OBJECTIVES: I. Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option. The first group receives tamoxifen by mouth every day for 5 years. The second group receive tamoxifen plus cyclophosphamide, methotrexate, fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6 courses; AC is given every 3 weeks for 4 courses. The third group receives tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin. The fourth group receives tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC. Postmenopausal women are randomized to the first or second groups. Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as follows: among all four groups; for chemotherapy alone (first versus second group); for ovarian suppression alone (first versus third group); for ovarian suppression with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy with nonrandomized assignment to ovarian suppression (second versus fourth group). Patients are followed for overall and relapse-free survival. PROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate - Stage I, II, or IIIA - Pathologically positive or negative nodes - Any size primary tumor No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall Hormone receptor status: Not specified --Prior/Concurrent Therapy-- No prior systemic treatment for breast cancer --Patient Characteristics-- Age: Not specified Sex: Female Menopausal status: Pre-, peri-, or postmenopausal Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior malignancy except: - Basal cell carcinoma - Carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnYarnold, Study Chair, United Kingdom Coordinating Committee on Cancer Research
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Cancer Research Campaign Trials Unit-Birmingham (CRCTU)
Birmingham, England, B15 2TT
United Kingdom
Additional Information:
Study ID Numbers: CDR0000063697; UKCCCR-ABC,EU-94029
Study Start Date: June 1994
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002582
Other Stage 3a Breast Cancer Studies:
1. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
2. Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
3. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
4. Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
5. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Scotland Clinical Trials
Other Glasgow Clinical Trials
Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
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