Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00245024
First received: October 25, 2005
Last updated: May 1, 2013
Last verified: October 2011

October 25, 2005
May 1, 2013
November 2005
August 2007   (final data collection date for primary outcome measure)
Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00245024 on ClinicalTrials.gov Archive Site
  • Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatment [ Designated as safety issue: No ]
  • NAG-1 induction and C-reactive protein (CRP) reduction before and after 6 weeks of treatment [ Designated as safety issue: No ]
  • Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and after 6 weeks of treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
  • Drug: sulindac
  • Other: laboratory biomarker analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2010
August 2007   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245024
CDR0000447144, P30CA023074, UARIZ-UAZ04-2-02, UARIZ-HSC-0553
Not Provided
H. H. Sherry Chow, Arizona Cancer Center at University of Arizona Health Science Center
National Cancer Institute (NCI)
University of Arizona
Study Chair: Patricia Thompson, PhD University of Arizona
National Cancer Institute (NCI)
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP