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Home > "C" Clinical Trials Conditions > Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women  Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): University of Kansas , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk women. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer.
Details: OBJECTIVES: - Determine the change in proliferation in benign breast epithelial cells as measured by Ki-67/MIB-1 in premenopausal women at high risk for estrogen receptor-negative breast cancer treated with celecoxib. - Determine the feasibility of this regimen by dropout rate of these patients during 12 months of treatment and compliance. - Determine the proportion of these women likely to express cyclooxygenase-2 protein (COX-2) in at least 10% of benign ductal epithelial cells. - Compare the success rate of obtaining adequate ductal epithelial cells by random periareolar fine needle aspiration (FNA) and ductal lavage in these patients before vs after 12 months of a prevention intervention. - Assess pain associated with FNA and ductal lavage in these women. - Correlate, if possible, serum proteomics pattern with cytologic assessment and mammographic density at baseline and at 12 months in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral celecoxib twice daily. Treatment continues for 12 months in the absence of clinical evidence of cancer confirmed by biopsy or unacceptable toxicity. Patients are assessed at baseline and at 12 months for mammographic breast density, serum hormone levels, and serum IGF-1/IGFBP-3. Patients undergo ductal lavage or fine needle aspiration for assessment of supernatant proteomics and breast biomarkers. Patients are followed at 2 weeks and then annually for 5 years. PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 10-14 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Increased risk for breast cancer on the basis of at least 1 of the following criteria: - Five-year Gail risk at least 1.7% or a calculated risk at least 5 times the average for age group - 20-29 years old - calculated 5-year Gail risk is at least 0.1% - 30-39 years old - calculated 5-year Gail risk is at least 1.0% - 40 and over - calculated 5-year Gail risk is at least 1.7% - Known BRCA1/BRCA2 mutation carrier - Family history consistent with hereditary breast cancer, as defined by any of the following circumstances: - At least 4 relatives with breast cancer at any age - At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger - Breast and ovarian cancer diagnosed in the same relative - At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family - Prior biopsy exhibiting atypical hyperplasia, lobular cancer in situ, ductal carcinoma in situ (DCIS)*, or invasive cancer** NOTE: *If DCIS or T1a or T1b disease was found, at least 2 months must have elapsed since prior surgery and/or radiotherapy to the involved breast NOTE: **Prior invasive cancer (T1c, T2, or T3) must have been diagnosed at least 2 years before study and be estrogen receptor-negative, node negative - Must have had a random periareolar fine needle aspiration successfully performed within the past 3 months, with at least 1,000 cells on cytology slide and 3 additional slides for biomarker analysis (1 with at least 500 cells for Ki-67 and 2 with at least 100 ductal cells for estrogen receptors and COX-2) - Hormone receptor status: - Estrogen receptor negative PATIENT CHARACTERISTICS: Age - 18 to 55 Sex - Female Menopausal status - Premenopausal, defined as menstrual periods estimated to occur every 21 to 35 days over the past 6 months Performance status - Not specified Life expectancy - At least 5 years Hematopoietic - Absolute granulocyte count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - No bleeding diathesis within the past year Hepatic - Bilirubin no greater than 2.0 mg/dL - Albumin at least 3.0 g/dL - AST and ALT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN - No severe liver disease requiring treatment Renal - Creatinine no greater than 1.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergy to sulfa, COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs (NSAIDs) - No history of an ulcer requiring treatment - No history of ulcerative colitis - No inflammatory bowel disease - No prior metastatic malignancy of any kind - No complications of alcoholism requiring hospitalization - No concurrent asthma being treated PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 6 months since prior chemotherapy Endocrine therapy - At least 6 months since prior antihormone therapy (e.g., selective estrogen-receptor modulators or aromatase inhibitors) - Anticipated use of oral or IV corticosteroids must be less than 2 weeks per year - No change (stop or start) in hormonal therapy within the past 6 months (e.g., estrogen, progesterone, oral contraceptives, or fertility agents) Radiotherapy - See Disease Characteristics - No prior radiotherapy to the contralateral breast involved in the study treatment Surgery - See Disease Characteristics Other - At least 3 weeks since prior aspirin, rofecoxib, celecoxib, other COX-2 inhibitors, or NSAIDs - No concurrent anticoagulants - No other concurrent NSAIDs - No chronic angiotensin-converting enzyme inhibitors - No chronic furosemide* - No chronic fluconazole* - No chronic lithium NOTE: *Occasional concurrent use allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolFabian, Study Chair, University of Kansas
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7820
United States
Recruiting Carol Fabian 913-588-7791
Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Seema Khan 312-695-4853
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting William Dooley 405-271-7867
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Samuel Beenken 205-934-2089
U.S. Oncology Research, Inc. *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Joyce O'Shaughnessy 214-370-1795
Additional Information:
Study ID Numbers: CDR0000271935; KUMC-HSC-8919-02
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056082
Other Breast Cancer Studies:
1. A Pilot Trial of Sequential Chemotherapy with Antimetabolite Induction, High-Dose Alkylating Agent Consolidation with Peripheral Blood Progenitor Cell Support, and Intensification with Paclitaxel and Doxorubicin for Patients with High-Risk Breast Cancer
2. Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study
3. Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
4. Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
5. Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
Related Studies:
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Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
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