Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Patricia Thompson

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00245024
Information obtained from ClinicalTrials.gov on December 14, 2011

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