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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| Cedars-Sinai Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulindac | Active Comparator | sulindac 150 mg |
|
| Placebo | Placebo Comparator | placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulindac Pill | Drug | Randomized participants will receive either 150 mg oral sulindac twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent breast density by MRI between treatment arms | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent breast density by MRI between treatment arms | 6 months | |
| Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison S Stopeck, MD | Stony Brook University | Principal Investigator |
| Patricia A Thompson-Carino, PhD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai - Cancer | Los Angeles | California | 90048 | United States | ||
| Stony Brook University Cancer Center |
There is no plan to share individual participant data to non study related researchers.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2026 | May 8, 2026 | 11 | ||
| May 20, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013467 | Sulindac |
| ID | Term |
|---|---|
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | placebo pills twice daily |
|
| Stony Brook |
| New York |
| 11794 |
| United States |
| Jun 15, 2026 |
| 12 |
| Jul 9, 2026 | Jul 9, 2026 | 13 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |