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A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer Clinical research trials and A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer. A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer clinical trial. Subjects frequently get the best healthcare possible for their A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer  A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer
A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer
For Condition: Breast Cancer,Breast Neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is an open-label phase II trial designed to study the safety and tolerability of raloxifene, a selective estrogen receptor modulating agent, in pre-menopausal women at high risk of developing invasive breast cancer. Two doses of raloxifene will be studied in sequential cohorts: a 60 mg dose (standard dose) and a 300 mg dose administered daily for 2 years. The primary objective of this trial will be to determine the safety of raloxifene in a pre-menopausal population using bone mineral density as the primary endpoint. Secondary objectives include assessment of endogenous hormones and lipid levels, menstrual cycle effects, effects on endometrium and ovaries, health related quality of life, and breast density. Tissue samples will be obtained for future studies of potential surrogate endpoint biomarkers.
Details: This is an open-label phase II trial designed to study the safety and tolerability of raloxifene, a selective estrogen receptor modulating agent, in pre-menopausal women at high risk of developing invasive breast cancer. One dose of raloxifene will be studied: a 60 mg dose (standard dose for post-menopausal women)will be administered daily for 2 years. The primary objective of this trial will be to determine the safety of raloxifene in a pre-menopausal population using bone mineral density at one year as the primary endpoint as well as the effect on breast density. Secondary objectives include assessment of endogenous hormones and lipid levels, menstrual cycle effects, effects on endometrium and ovaries, health related quality of life. Tissue samples will be obtained for future studies of potential surrogate endpoint biomarkers.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Women must be between 23-47 years and shall be pre-menopausal as determined by menstrual history (no change in menstrual pattern in prior 6 months) and an early follicular or luteal phase FSH level less than 20 mIU/ml. Women must be at risk for developing invasive breast cancer by virtue of one of the following criteria: Gail Model risk equal to that of an average 60 year old woman as determined using the Gail risk assessment model (Gail, 1989). This model is available on the Risk Disc issued by the NCI and at the web address: http://bcra.nci.nih.gov/brc/. The minimum risk a person must have to be eligible by this model is 1.7% over 5 years from study entry. This is the same minimum level of risk required for a subject to be eligible for the recently completed NSABP-P1 tamoxifen breast cancer prevention trial. Lobular neoplasia. Atypical ductal hyperplasia in a subject with a positive family history of breast cancer. DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation. BRCA1 or 2 mutation positive genotyping. Family history consistent with hereditary cancer syndrome of increased breast cancer risk as defined below. The estimated probability of families with these patterns having a BRCA1 mutation is greater than 10%. Family with greater than 2 breast cancer cases and one or more cases of ovarian cancer diagnosed at any age; Family with greater than 3 breast cancer cases diagnosed before age 50; Sister pairs with two of the following cancers diagnosed before age 50: two breast cancers, two ovarian cancers, or a breast and ovarian cancer. Women must be willing to use effective non-hormonal methods of contraception (barrier methods and spermicides, surgical methods) for the duration of the study and 3 months after completing study drug. Subjects must be able to provide informed consent. EXCLUSION CRITERIA: Women post-hysterectomy, pregnant women, and lactating women will be excluded. Women with menstrual cycle abnormalities, including cycles less than 26 days or more than 35 days, irregular cycles, dysfunctional uterine bleeding, menorrhagia. Known allergy to study drug. Subjects may not have had steroid therapy (including tamoxifen, estrogen, DHEA, anabolic steroids, oral contraceptives) within 6 months prior to study entry. History of infertility with a suspected ovarian etiology or recurrent ovarian cysts. History of pulmonary embolism or deep venous thrombosis. History of bleeding disorder. History of cirrhosis of the liver. Creatinine of greater than 1.7. SGOT/SGPT greater than 3 times the upper limit of normal. Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude administration of the study drug. Subjects who, in the opinion of the Principal Investigator, are not at increased risk of having a BRCA mutation, will not be eligible unless they meet criteria listed under inclusion 2. Women currently using intrauterine device contraceptives. Cervical dysplasia or significant uterine pathology potentially requiring surgery during the study period. Women with abnormal CA-125 levels.
Total Enrollment: 41
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980123; 98-C-0123
Study Start Date: June 26, 1998
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001700
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2. Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
3. Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study
4. A Study of ALIMTA (pemetrexed) Plus Carboplatin for the Treatment of Patients with Locally Advanced or Metastatic Breast Cancer
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A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer
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