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Clinical Trials/NCT00245024
NCT00245024CompletedPhase 1

Phase IB Sulindac Study for Women at High Risk for Breast Cancer

National Cancer Institute (NCI)1 site in 1 country30 target enrollmentStarted: November 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 studying the effects of sulindac, to prevent breast cancer, in women at high risk for breast cancer.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion 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:
  • •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
  • •Bilirubin ≤ 2.0 mg/dL
  • •AST and ALT ≤ 2.0 times upper limit of normal
  • •No indication of abnormal liver function
  • •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
  • •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)
  • +16 more not shown

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment

Secondary Outcomes

  • 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

Investigators

Sponsor Class
Nih

Study Sites (1)

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