Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: sulindac (Drug); laboratory biomarker analysis (Other)
Phase: Phase 1
Status: Completed
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s): Patricia Thompson, PhD, Study Chair, Affiliation: University of Arizona
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 studying the effects of sulindac, to prevent
breast cancer, in women at high risk for breast cancer.
Clinical Details
Official title: Phase IB Sulindac Study for Women at High Risk for Breast Cancer
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
Secondary outcome: Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatmentNAG-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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724-5024, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 2005
Last updated: May 1, 2013
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