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


Phase 1
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

Phase IB Sulindac Study for 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.

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:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Patricia Thompson, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000447144

NCT ID:

NCT00245024

Start Date:

November 2005

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • breast cancer
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • breast cancer in situ
  • Breast Neoplasms

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724