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
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Density
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.
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
No
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
No
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
Email
pushpa.talanki@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caterina Vacchi-Suzzi, PhD
Phone
631-216-2993
Email
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
Email
Jane.Ngo@cshs.org
First Name & Middle Initial & Last Name & Degree
Patricia Thompson, PhD
Email
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
Email
pushpa.talanki@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Caterina Vacchi-Suzzi, PhD
Phone
631-216-2993
Email
caterina.vacchi-suzzi@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Alison Stopeck, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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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