- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00245024
Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Phase IB Sulindac Study for Women at High Risk for Breast Cancer
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 studying the effects of sulindac, to prevent breast cancer, in women at high risk for breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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 6 weeks of therapy.
Secondary
- Determine prostaglandin levels in the NAF of patients treated with this drug.
- Determine if NAG-1 levels are induced in the NAF of patients treated with this drug.
- Determine if C-reactive protein levels are reduced in the NAF of patients treated with this drug.
- Determine if NAG-1 levels and/or karyometric features in ductal epithelial cells are modulated in patients treated with this drug.
OUTLINE: This is a randomized, open-label study.
Patients undergo nipple aspirate fluid (NAF) collection. Patients are then randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sulindac once daily.
- Arm II: Patients receive oral sulindac twice daily. In both arms, treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. All patients then undergo a second NAF collection.
After completion of study treatment, patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatment
|
NAG-1 induction and C-reactive protein (CRP) reduction before and after 6 weeks of treatment
|
Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and after 6 weeks of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Patricia Thompson, PhD, University of Arizona
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Sulindac
Other Study ID Numbers
- CDR0000447144
- P30CA023074 (U.S. NIH Grant/Contract)
- UARIZ-UAZ04-2-02
- UARIZ-HSC-0553
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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