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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 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

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

Page last updated: August 23, 2015

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