NSAID Effects on Clinical and Imaging Breast Biomarkers

NCT01761877 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 1RO1 CA1615301A112-0080-04676847
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.

Conditions

Inflammation; Cancer; Pain; Hypertension

Keywords

breast cancer, breast density, chemoprevention

Outcome Measures

Primary Outcomes (1)

• Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging

  Adjusted estimates of relative change in percent breast density by magnetic resonance imaging

  Baseline and 12 months

Secondary Outcomes (1)

• Muscle and Joint Pain and Stiffness

  Baseline and 12 months

Other Outcomes (1)

• Change in Mean Arterial Blood Pressure at 12 Months

  Change in blood pressure between Baseline and 12 months

Study Arms (2)

Sulindac (Clinoril)

EXPERIMENTAL

Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will receive 150 mg of sulindac twice daily for 12 months. They will receive up to 4 MRI within 12 months.

Drug: Sulindac

Observational

NO INTERVENTION

Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will continue their treatment will be monitored with MRI and standard of care tests every 6 months for up to 12 months.

Interventions

Sulindac DRUG

Also known as: Clinoril

Sulindac (Clinoril)

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
• Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
• Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of \> 25% as measured by standard digital mammography (BIRADs score \> 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study
• A willingness to follow the study protocol, as indicated by provision of informed consent to participate
• A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
• Normal renal function as determined by a serum creatinine \< upper limit of normal
• No known contraindication to NSAID use
• Normotensive or controlled blood pressure (\< 140/90) on a single anti-hypertensive medication

You may not qualify if:

• Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
• Known intolerance to NSAIDs
• Age \> 75 years
• History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
• Diabetes requiring drug therapy
• Current smoker
• History of Uncontrolled hypertension
• Blood pressure \> 140/90 at baseline by home monitoring
• History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
• History of a bleeding diathesis or current anticoagulant therapy
• Daily therapy with H2 blockers or protein pump inhibitors
• History of claustrophobia
• Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (2)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• Martinez JA, Wertheim BC, Roe DJ, Chalasani P, Cohen J, Baer L, Chow HS, Stopeck AT, Thompson PA. Sulindac Improves Stiffness and Quality of Life in Women Taking Aromatase Inhibitors for Breast Cancer. Breast Cancer Res Treat. 2022 Feb;192(1):113-122. doi: 10.1007/s10549-021-06485-0. Epub 2022 Jan 18.

  PMID: 35039952 DERIVED

MeSH Terms

Conditions

Inflammation; Neoplasms; Pain; Hypertension; Breast Neoplasms

Interventions

Sulindac

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Alison T Stopeck
• Organization: Stony Brook University

Alison.Stopeck@stonybrookmedicine.edu

5206476982

Study Officials

• Patricia Thompson-Carino, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

• Alison Stopeck, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

• Pavani Chalasani, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 7, 2013
• Study Start: December 1, 2012
• Primary Completion: February 7, 2019
• Study Completion: March 11, 2019
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Locations

US (2)