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A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer Clinical research trials and A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer. A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer  A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer
A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer
For Condition: Breast Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The primary goal of this 5-year study is to determine whether exemestane alone or in combination with celecoxib decreases breast tissue density in healthy postmenopausal women at high risk for breast cancer. Dense breast tissue seen on mammography has been linked to an increased risk of breast cancer. The study will also look at the effects of exemestane and celecoxib on bone density, blood hormone levels and quality of life. Exemestane, approved by the Food and Drug Administration for treating postmenopausal women with breast cancer, lowers the amount of estrogen in the body. Celecoxib, approved for treating arthritis pain and for reducing the number or colon polyps in an inherited syndrome, is an anti-inflammatory drug. Half of the women in the study will receive exemestane alone and half will receive exemestane and celecoxib together. Postmenopausal women (defined in this study as women who have not had a menstrual period for at least 12 months or who have had both ovaries removed) who are at increased risk for developing invasive breast cancer may be eligible to participate. Candidates will be screened with breast cancer risk assessment, medical history and physical examination, blood tests, review of medical records if needed, and dual energy x-ray absorptiometry (DEXA) scan to assess bone density. For the DEXA scan, the subject lies still on a table for about 30 minutes while the spine and hip are scanned using a small amount of radiation. A breast biopsy (surgical removal of a small sample of breast tissue for examination)will be done if the candidate enrolls on the trial. Participants will take exemestane or exemestane and celecoxib by mouth in pill form once a day for 5 years. They will also take calcium and vitamin D pills daily to help protect bone health. They will be followed in the clinic during the course of the study to determine the amount of drug taken and any side effects, and for the following tests and procedures: - Medical evaluation and blood tests at after 1 and 3 months on study drugs - Medical evaluation at 6 months - Breast biopsy at 12 months - DEXA scan of the spine, mammogram and routine blood tests at 12 months and then yearly for 5 years - Breast examination, review of side effects, and refill of study drugs every 6 months for 5 years - Quality of life questionnaire before starting study drugs and after 1 year and 5 years on study drugs
Details: This is an open label sequential phase 2 two-arm study of exemestane alone or in combination with celecoxib in postmenopausal women with an elevated risk of developing invasive breast cancer. Seventy-two subjects will be enrolled. The first group of 36 subjects will receive standard dose exemestane (25 mg QD) and celecoxib (400 mg QD). The second group of 36 subjects will receive standard dose exemestane (25 mg QD) alone. Each subject will continue treatment for a total of five years. The primary objective is to evaluate the study drug(s) effects on mammographic density after one year on treatment. Secondary objectives include assessing the effect of the intervention on bone mineral density, serum hormones and lipids, and breast tissue biomarkers. Changes in mammographic breast density and bone mineral density will be evaluated annually which will provide long term biomarker and safety information about prevention therapy with exemestane and celecoxib.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Postmenopausal female. Postmenopausal defined as no menses for at least 12 months or bilateral oopherectomy. In unclear cases, (e.g. 50 year old who has had hysterectomy) chemical confirmation of postmenopausal status may be confirmed with FSH greater than 35 U/L. Elevated risk for developing invasive breast cancer by virtue of one of the following criteria: Gail Model risk of greater than or equal to 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. DCIS (ductal carcinoma in situ) that has been previously treated with mastectomy or lumpectomy and radiation, +/- tamoxifen. Deleterious mutations in BRCA1 or 2 OR A priori risk assessment of 20% chance or greater of carrying BRCA1/2 gene mutation. The BRCAPRO and Couch model will both be used to asses this risk. If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria. Subjects should be willing to abstain from use of hormonal therapies (e.g. tamoxifen, hormone replacement therapy, oral contraceptive pills, hormone-containing IUDs.E-string is acceptable) and chronic NSAIDs for the duration of the study (chronic use of NSAIDs is defined as a frequency greater than 3 times/week for more than two weeks per year and includes low dose aspirin). Vitamin E and venlafaxine will be offered as supportive care for women with menopausal symptoms. Acetaminophen will be offered for pain control. ECOG performance status 0-1. Subject has been counseled regarding her options and has signed the informed consent document. Baseline DEXA scan with BMD T-score greater than or equal to 1.5 at AP spine. Hemoglobin greater than or equal to 11 g/dl. Creatinine less than 1.5 times the upper limits of normal. ALT or AST less than 2.5 times upper limit of normal. No investigational agent for the past 30 days. If history of cancer (other than invasive breast cancer, squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceeding enrollment. EXCLUSION CRITERIA: Current or recent chronic use (within 6 months) of hormonal medications, e.g. oral contraceptive pills, hormone replacement therapy, tamoxifen, raloxifene, IUD with progestins or corticosteroids. Subjects on chronic topical or inhaled steroids will not be eligible for the study. Use of aspirin, NSAIDs, celecoxib or rofecoxib within last 72 hours. Current use of phenytoin, carbamazepine, rifampin due to increased estrogen metabolism. Current use of warfarin, fluconazole, lithium due to potential interactions with celecoxib. (If a subject is required to start warfarin after she is enrolled, she will not need to be taken off study). A history of gastric ulcers, peptic ulcer disease or gastrointestinal bleeding, active GI disease (e.g., inflammatory bowel disease), a chronic or acute renal, hepatic or pancreatic disorder, or any other condition which, in the opinion of the Investigator, might preclude the use of an NSAID (e.g., congestive heart failure). History of clotting or bleeding disorder. History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane (e.g. anastrozole, letrozole, formestane) or celecoxib (e.g. rofecoxib). Aspirin sensitive asthma. Allergy to sulfonamides. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. History of invasive breast cancer.
Total Enrollment: 72
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040044; 04-C-0044
Study Start Date: November 13, 2003
Record last reviewed: November 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073073
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2. Inflammatory Breast Cancer and Tumor Markers
3. Study of ABI-007 and Taxol in Patients with Metastatic Breast Cancer
4. OSI-774 to Treat Advanced Breast Cancer
5. A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab
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A trial of exemestane alone or in combination with celecoxib in postmenopausal women with DCIS or at high risk for invasive breast cancer
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