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Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer Clinical research trials and Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer. Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer  Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane plus goserelin may fight breast cancer by reducing the production of estrogen. PURPOSE: Phase II trial to study the effectiveness of exemestane and goserelin in treating premenopausal women who have metastatic breast cancer that has not responded to previous tamoxifen.
Details: OBJECTIVES: I. Determine the efficacy of exemestane and goserelin in premenopausal women with hormone receptor positive metastatic breast cancer after tamoxifen failure. II. Determine the toxicity of this regimen in these patients. III. Determine the hormonal profile of patients treated with this regimen. IV. Determine the predictive value of HER-2, epidermal growth factor receptor, and estrogen receptor for response in patients treated with this regimen. PROTOCOL OUTLINE: Patients receive oral exemestane daily on days 1-28 and goserelin subcutaneously on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed metastatic breast cancer that has failed prior tamoxifen therapy - Measurable disease - No CNS metastases - Hormone receptor status: Estrogen or progesterone receptor positive; At least 10 fmol/L by biochemical assay OR At least 10% of cells positive by immunochemistry --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 2 prior chemotherapy regimens - Endocrine therapy: See Disease Characteristics; No prior hormonal therapy for metastatic breast cancer; No concurrent estrogen (hormone replacement) therapy; No other concurrent hormonal agents for breast cancer (e.g., tamoxifen, anastrozole, letrozole, aminoglutethimide, or megestrol); No concurrent corticosteroids for breast cancer unless already receiving such therapy at study entry - Radiotherapy: Not specified - Surgery: Not specified - Other: Concurrent bisphosphonates allowed for bone disease provided measurable disease in non-osseous sites; No concurrent anticoagulant therapy --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Premenopausal defined as estradiol at least 30 pg/mL, follicle stimulating hormone less than 25 mIU/mL, and luteinizing hormone less than 15 mIU/mL - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 50,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; AST no greater than 3 times normal - Renal: Stable renal function - Pulmonary: No pulmonary embolism - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective non-hormonal contraception during and for 12 weeks after study; No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix; No known hypersensitivity to luteinizing hormone releasing hormone (LHRH), LHRH agonist analogues, or any of the components of goserelin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnneHamilton, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000068431; NYU-0004,NCI-G00-1906,P-UPJOHN-NYU-0004
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010010
Other Stage 4 Breast Cancer Studies:
1. Vaccine Therapy in Treating Patients With Breast Cancer
2. Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women with Metastatic Breast Cancer
3. Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
4. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
5. Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
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Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
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