Status:
COMPLETED
Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
University of Arizona
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent breast cancer. PURPOSE: This randomized phase I trial is s...
Detailed Description
OBJECTIVES: Primary * Determine the partitioning of sulindac and its metabolites in women at high risk for breast cancer by measuring drug and metabolite levels in nipple aspirate fluid (NAF) after ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Gail assessment score \> 1.7% risk for 5 years
- History of lobular carcinoma in situ (pathology report required)
- History of ductal carcinoma in situ (DCIS) (pathology report required)
- History of breast cancer in ≥ 1 first-degree relative or history of BRCA1 or BRCA2 positivity not treated with oophorectomy or mastectomy (test report required)
- History of breast cancer in ≥ 2 second-degree relatives
- Any family history of breast cancer diagnosed prior to age 50
- Personal history of breast cancer (invasive or DCIS) with 1 breast intact
- Nipple aspirate fluid production ≥ 5 microliters
- Negative mammogram for breast cancer within the past 10 months
- Any suspicious breast masses must be examined by a clinical professional
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Sex
- Female
- Menopausal status
- Pre- or postmenopausal
- Performance status
- Karnofsky 80-100%
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No history of bleeding or clotting disorder
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.0 times upper limit of normal
- No indication of abnormal liver function
- Renal
- Creatinine normal
- Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Gastrointestinal
- No frequent, chronic, or moderate/severe gastric complaint
- No upper gastrointestinal problems (e.g., symptoms of heartburn, dyspepsia, or abdominal pain) requiring prescription or nonprescription medical remedies more than once per week (on average)
- No history of peptic ulcer or occult or gross intestinal bleeding
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction (e.g., urticaria, asthma, rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac
- No history of allergy attributed to lidocaine, EMLA® cream, or xylocaine
- No concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No more than 2-3 servings of alcohol per week during study participation
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- More than 6 months since prior chemotherapy for breast cancer (invasive or DCIS)
- Endocrine therapy
- More than 6 months since prior hormonal therapy for breast cancer (invasive or DCIS)
- No concurrent hormone-suppressing agents (e.g., tamoxifen or anastrozole)
- No concurrent selective estrogen-receptor modulators
- No concurrent aromatase inhibitors
- Radiotherapy
- More than 6 months since prior radiotherapy for breast cancer (invasive or DCIS)
- Surgery
- See Disease Characteristics
- No prior breast duct-disrupting surgery (e.g., mastectomy) that would preclude ductoscopy
- Other
- More than 3 months since prior warfarin or other systemic anticoagulant
- More than 4-6 weeks since prior nonsteroidal anti-inflammatory drugs
- No concurrent phenytoin or sulfonamides
- No concurrent warfarin or other systemic anticoagulant
- No other concurrent nonsteroidal anti-inflammatory drugs (including low-dose aspirin)
- No concurrent large doses of supplements, vitamins (\> regular daily multivitamin) and/or herbal medicines (e.g., echinacea, ginkgo biloba, Hypericum perforatum \[St. John's wort\], or herbal tea)
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00245024
Start Date
November 1 2005
End Date
January 1 2010
Last Update
May 3 2013
Active Locations (1)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024