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ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer Clinical research trials and ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer. ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer  ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ERA-923 may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of ERA-923 in treating postmenopausal women who have metastatic breast cancer that no longer responds to tamoxifen.
Details: OBJECTIVES: I. Compare the efficacy of 2 dose levels of ERA-923 in postmenopausal patients with metastatic breast cancer refractory to tamoxifen. II. Determine the safety and plasma levels of this drug in these patients. III. Determine the impact on quality of life of these patients by this drug. PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of two treatment arms receiving different doses of ERA-923. Patients receive oral ERA-923 daily for 48 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline; at weeks 4, 8, 16, 24, 32, 40, and 48; and then at 4 weeks after last dose. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: At total of 36-100 patients (18-50 per arm) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of metastatic breast cancer - Prior tamoxifen therapy failure within 1 year of study defined as follows: Prior tamoxifen therapy for metastatic disease with prior response and progression of disease while still on treatment or within 1 year of last treatment; Prior adjuvant tamoxifen therapy for a minimum of 2 years with subsequent progression of disease while still on treatment or within 1 year of last treatment - Postmenopausal; Must be amenorrheic for at least 12 months; Removal of both ovaries or chemotherapy induced menopause allowed - At least 1 bideminsionally measurable lesion - No disease restricted only to bone - No symptomatic CNS metastases untreated by surgery or radiotherapy - Hormone receptor status: Estrogen or progesterone receptor positive --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent trastuzumab (Herceptin) - Chemotherapy: No more than 2 prior chemotherapy regimens, including trastuzumab; One regimen in adjuvant setting and one in metastatic setting OR Two regimens in metastatic setting; No concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; At least 6 months since prior raloxifene for osteoporosis; No prior hormonal, antiestrogen, or aromatase inhibitors other than tamoxifen for breast cancer At least 4 weeks since prior tamoxifen; No concurrent hormonal replacement therapy, other antiestrogens (including raloxifene), aromatase inhibitors, or systemic steroids (except physiologic replacement doses) - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics - Other: At least 4 weeks since prior investigational drug; No concurrent warfarin exept low dose warfarin for port maintenance; No other concurrent investigational agent; No concurrent immunosuppressive therapy --Patient Characteristics-- - Age: Not specified - Menopausal status: Postmenopausal - Performance status: ECOG 0-2 - Life expectancy: At least 6 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 9.0 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present); PT and PTT no greater than 1.25 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No deep vein thrombosis, retinal vein thrombosis, or stroke within past year; No unstable angina or myocardial infarction within past 6 months - Pulmonary: No pulmonary embolism within past year - Other: Not pregnant or nursing; No other major illness or condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanMinton, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000068242; MCC-12235,W-AR-3077A1-200-US,NCI-G00-1871,MCC-IRB-5757,GENE-C9944-33
Study Start Date: June 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006369
Other Recurrent Breast Cancer Studies:
1. Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
2. Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
3. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
4. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
5. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
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ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
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