|
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive 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 Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer Clinical research trials and Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive 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 Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive 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 Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive 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.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer  Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
For Condition: stage 3C breast cancer,stage 3A breast cancer,stage 3B breast cancer,stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Randomizedphase I trial to study the effectiveness of celecoxib in treating postmenopausal women who have invasive breast cancer and are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center.
Details: OBJECTIVES: Primary - Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery. Secondary - Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients. - Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients. - Determine whether any observed biological effect of this drug is dose-dependent in these patients. - Identify collateral targets (COX-2-independent) of this drug in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity. - Arm II: Patients receive a higher dose of oral celecoxib as in arm I. - Arm III: Patients do not receive treatment. All patients undergo definitive surgery. PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast carcinoma - Tumor at least 1 cm by radiologic estimate or physical exam - No disease limited to ductal carcinoma in situ only - Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Female Menopausal status - Postmenopausal as defined by at least 1 of the following: - No menstrual period within the past 12 months - Prior bilateral oophorectomy Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - No known liver disease Renal - No renal insufficiency Cardiovascular - No congestive heart failure - No coronary artery disease Gastrointestinal - No history of documented peptic ulcer disease - No gastritis Other - No medical condition that would preclude definitive surgery - No allergy to NSAIDs or sulfa-containing drugs - No connective tissue diseases, including any of the following: - Systemic lupus erythematosus - Reynaud's disease - Scleroderma PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 3 months since prior chemotherapy Endocrine therapy - More than 2 weeks since prior hormone replacement therapy - More than 2 weeks since prior tamoxifen - More than 2 weeks since prior aromatase inhibitors - More than 2 weeks since prior raloxifene - More than 2 weeks since prior steroids Radiotherapy - Not specified Surgery - See Disease Characteristics Other - More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs) - More than 1 week since prior cyclooxygenase (COX)-2 inhibitors - No concurrent warfarin - No concurrent thiazide or loop diuretics - No concurrent COX-2 inhibitors - No concurrent NSAIDs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CliffordHudis, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Elisa Port 212-639-5461
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Andrew Dannenberg 212-746-4403
Additional Information:
Study ID Numbers: CDR0000329919; MSKCC-03027
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070057
Other Stage 3a Breast Cancer Studies:
1. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
2. Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Who Have Not Responded to Previous Anthracycline-Based Chemotherapy
3. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
4. Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast
5. Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
|
|
|
|
|
|
|
|
