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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sulindac Pill

Placebo

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Density

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Cedars Sinai - CancerRecruiting
Stony Brook University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sulindac

Placebo

Arm Description

sulindac 150 mg

placebo pill

Outcomes

Primary Outcome Measures

Change in percent breast density by MRI

Secondary Outcome Measures

Changes in collagen type in breast tissue by whole slide mass spectrometry of tissue biopsy

Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy

Full Information

NCT ID

NCT04542135

First Posted

August 27, 2020

Last Updated

March 7, 2023

Sponsor

Stony Brook University

Collaborators

Medical University of South Carolina, Cedars-Sinai Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04542135

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 20, 2020 (Actual)

Primary Completion Date

October 31, 2026 (Anticipated)

Study Completion Date

February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stony Brook University

Collaborators

Medical University of South Carolina, Cedars-Sinai Medical Center

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Density

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sulindac

Arm Type

Active Comparator

Arm Description

sulindac 150 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo pill

Intervention Type

Drug

Intervention Name(s)

Sulindac Pill

Intervention Description

Randomized participants will receive either 150 mg oral sulindac twice daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo pills twice daily

Primary Outcome Measure Information:

Title

Change in percent breast density by MRI

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Changes in collagen type in breast tissue by whole slide mass spectrometry of tissue biopsy

Time Frame

6 months

Title

Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pushpa Talanki

Phone

631-638-0815

pushpa.talanki@stonybrookmedicine.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Caterina Vacchi-Suzzi, PhD

Phone

631-216-2993

caterina.vacchi-suzzi@stonybrookmedicine.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison S Stopeck, MD

Organizational Affiliation

Stony Brook University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Patricia A Thompson-Carino, PhD

Organizational Affiliation

Stony Brook University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai - Cancer

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jane Ngo

Jane.Ngo@cshs.org

First Name & Middle Initial & Last Name & Degree

Patricia Thompson, PhD

patricia.thompson@cshs.org

First Name & Middle Initial & Last Name & Degree

Farin Amersi, MD

Facility Name

Stony Brook University Cancer Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pushpa Talanki

Phone

631-638-0815

pushpa.talanki@stonybrookmedicine.edu

First Name & Middle Initial & Last Name & Degree

Caterina Vacchi-Suzzi, PhD

Phone

631-216-2993

caterina.vacchi-suzzi@stonybrookmedicine.edu

First Name & Middle Initial & Last Name & Degree

Alison Stopeck, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share individual participant data to non study related researchers.

Learn more about this trial

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

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