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

NCT00245024 | Completed Phase 1

• 4 other identifiers: CDR0000447144P30CA023074UARIZ-UAZ04-2-02UARIZ-HSC-0553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; ductal breast carcinoma in situ; lobular breast carcinoma in situ; breast cancer in situ

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

sulindac DRUG

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• University of Arizona: collaborator

Study Sites (1)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

Related Publications (1)

• Thompson PA, Huang C, Yang J, Wertheim BC, Roe D, Zhang X, Ding J, Chalasani P, Preece C, Martinez J, Chow HS, Stopeck AT. Sulindac, a Nonselective NSAID, Reduces Breast Density in Postmenopausal Women with Breast Cancer Treated with Aromatase Inhibitors. Clin Cancer Res. 2021 Oct 15;27(20):5660-5668. doi: 10.1158/1078-0432.CCR-21-0732. Epub 2021 Jun 10.

  PMID: 34112707 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Interventions

Sulindac

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Patricia Thompson, PhD

  University of Arizona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: January 1, 2010
• Last Updated: May 3, 2013

Record last verified: 2011-10

Locations

US (1)