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

Sponsor

Stony Brook University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04542135

Collaborator

Medical University of South Carolina (Other), Cedars-Sinai Medical Center (Other)

150

Enrollment

Locations

Arms

59.4

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Sulindac Pill Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in percent breast density by MRI [12 months]

Secondary Outcome Measures

Changes in collagen type in breast tissue by whole slide mass spectrometry of tissue biopsy [6 months]
Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai - Cancer	Los Angeles	California	United States	90048
2	Stony Brook University Cancer Center	Stony Brook	New York	United States	11794

Sponsors and Collaborators

Stony Brook University
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patricia Thompson-Carino, Principal Investigator, Stony Brook University

ClinicalTrials.gov Identifier:

NCT04542135

Other Study ID Numbers:

STOP-BC Trial

First Posted:

Sep 9, 2020

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Patricia Thompson-Carino, Principal Investigator, Stony Brook University

Breast Density

Additional relevant MeSH terms:

Breast Neoplasms

Sulindac

Study Results

No Results Posted as of Feb 24, 2022