Sulindac and Breast Density in Women at Risk of Developing Breast Cancer

Double-blind, Randomized Phase II Clinical Trial of Sulindac for Reducing Breast Density in Postmenopausal Women at Risk of Developing Breast Cancer

The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Sulindac Pill; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Caterina Vacchi-Suzzi, PhD; Phone Number: 631-216-2993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu
• Study Contact Backup: Name: Pushpa Talanki; Phone Number: 631-638-0815; Email: pushpa.talanki@stonybrookmedicine.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai - Cancer
      • Contact: Patricia Thompson, PhD; Email: patricia.thompson@cshs.org
      • Contact: Brenda Figueroa; Phone Number: 323-449-6443; Email: Brenda.Figueroa3@cshs.org
      • Principal Investigator: Patricia Thompson, PhD
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Cancer Center
      • Contact: Caterina Vacchi-Suzzi, PhD; Phone Number: 631-216-2993; Email: caterina.vacchi-suzzi@stonybrookmedicine.edu
      • Contact: Pushpa Talanki; Phone Number: 631-638-0815; Email: pushpa.talanki@stonybrookmedicine.edu
      • Principal Investigator: Alison Stopeck, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≤70 years
2. Subject must be postmenopausal.
3. Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable.
4. Must have dense breasts
5. Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition
6. A negative fecal occult blood test
7. Normal organ function
8. Hormonal therapy with aromatase inhibitors is allowed

Exclusion Criteria:

1. Daily aspirin or other daily anti inflammatory use.
2. Known intolerance to anti inflammatory.
3. Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months
4. Gastrointestinal, bleeding or coagulation, cardiovascular disorders.
5. Diabetes requiring insulin therapy.
6. Current regular smoker.
7. History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging.
8. Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI.
9. Uncontrolled hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sulindac; sulindac 150 mg	Drug: Sulindac Pill; Randomized participants will receive either 150 mg oral sulindac twice daily.
Placebo Comparator: Placebo; placebo pill	Drug: Placebo; placebo pills twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in percent breast density by MRI between treatment arms	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in percent breast density by MRI between treatment arms	6 months
Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy	12 months
Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors	12 months

Collaborators and Investigators

• Sponsor: Alison Stopeck
• Collaborators: Medical University of South Carolina; Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Alison S Stopeck, MD, Stony Brook University; Principal Investigator: Patricia A Thompson-Carino, PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Estimated): January 29, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Breast Density
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Sulindac
• Other Study ID Numbers: STOP-BC Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data to non study related researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes