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Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer Clinical research trials and Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer. Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer  Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer
Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer
For Condition: stage 3 breast cancer,inflammatory breast cancer,Quality of Life
Status: No longer recruiting
Sponsor(s): Scottish Cancer Therapy Network ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell transplantation is more effective than standard chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard chemotherapy with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating women who have advanced breast cancer or inflammatory breast cancer.
Details: OBJECTIVES: I. Compare the overall survival in locally advanced, inflammatory, or operable large primary breast cancer (greater than 3 cm) patients with positive axillary lymph nodes at surgery following primary chemotherapy, receiving either conventional chemotherapy or high dose chemotherapy as adjuvant therapy. II. Compare the relapse-free survival and quality of life in these patients receiving this therapy. PROTOCOL OUTLINE: This is a randomized, multicenter, open label study. Patients are stratified by study center and number of positive axillary lymph nodes at surgery. Patients are randomized to receive conventional or high dose adjuvant chemotherapy. Arm I: Patients receive conventional chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil IV administered once every 3 weeks for 8 courses. Arm II: Patients receive high dose chemotherapy. Cyclophosphamide IV is administered on day 1. Patients undergo peripheral blood progenitor cell (PBPC) collection, then receive cyclophosphamide and thiotepa IV for 4 days, 13-28 days after PBPC collection. Peripheral blood progenitor cells are then reinfused. Patients undergo radiotherapy during or after chemotherapy and receive oral tamoxifen for 5 years, beginning at the same time as radiotherapy. Estrogen receptor negative patients may receive tamoxifen at the discretion of the treating physician. Quality of life is assessed before chemotherapy, then at 6, 12, and 24 months. Patients are followed at 12, 18, and 24 months, then annually for 5 years or until death. PROJECTED ACCRUAL: This study will accrue approximately 300 patients.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven locally advanced, inflammatory, or operable large primary breast cancer (greater than 3 cm) following 2-6 courses of primary anthracycline-containing chemotherapy - Potentially curative surgery - At least 1 axillary lymph node involvement at surgery - No metastatic disease - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Prior surgery required --Patient Characteristics-- - Age: 18 to 60 - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL - Hepatic: Normal prothrombin time; Normal activated partial thromboplastin time; Normal bilirubin (except for patients with benign congenital hyperbilirubinemia); AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 1.5 times ULN; No active hepatitis B or C infection - Renal: Normal creatinine - Cardiovascular: Adequate cardiac function; No active cardiac disease; Left ventricular ejection fraction within normal range - Other: No other serious medical or psychiatric disease; Not pregnant; No prior/concurrent malignancy except basal cell carcinoma of the skin or carcinoma in situ of the cervix; HIV negative OR asymptomatic for HIV disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
T.R.J.Evans, Study Chair, Scottish Cancer Therapy Network
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066782; SCTN-BR9810,EU-98054
Study Start Date: November 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003680
Other Inflammatory Breast Cancer Studies:
1. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
2. Study to Assess Cancer Patients' Satisfaction With Hospital Quality of Care
3. Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
4. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Effect of Chemotherapy Given Either by Mouth or by Infusion on the Quality of Life of Patients With Recurrent Ovarian Epithelial Cancer
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Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer
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