The PROMISE Study: Duavee in Women With DCIS
Public ClinicalTrials.gov record NCT02694809. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Large-scale Multicenter Phase II Study Evaluating the Protective Effect of a Tissue Selective Estrogen Complex (TSEC) in Women With Newly Diagnosed Ductal Carcinoma in Situ
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Study identification
- NCT ID
- NCT02694809
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Interventions
- Conjugated Estrogens/Bazedoxifene Drug
- Laboratory Biomarker Analysis Other
- Pharmacological Study Other
- Placebo Other
- Quality-of-Life Assessment Procedure
- Questionnaire Administration Other
Drug · Other · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2017 (Type not available)
- Primary completion
- Jun 19, 2024 (Actual)
- Completion
- Jun 19, 2024 (Actual)
- Last update posted
- Jan 28, 2025
2017 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado at Denver/ Department of Surgery | Aurora | Colorado | 80045 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Northwestern Medicine - Delnor/Warrenville Cancer Centers/Central DuPage Hospital | Geneva | Illinois | 60134 | — |
| Northwestern University | Lake Forest | Illinois | 60045 | — |
| John's Hopkins University | Baltimore | Maryland | 21287 | — |
| Dana Farber/Partners Cancer Care Inc | Boston | Massachusetts | 02115 | — |
| Washington University in St. Louis/ Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburg/ Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02694809, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02694809 live on ClinicalTrials.gov.