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Clinical trialNCT02694809CompletedPhase 2Interventional

The PROMISE Study: Duavee in Women With DCIS

SponsorNorthwestern UniversityEnrollment142Ductal Breast Carcinoma In SituPostmenopausal
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Colorado at Denver/ Department of Surgery

    Aurora, Colorado, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Northwestern Medicine - Delnor/warrenville Cancer Centers/central Dupage Hospital

    Geneva, Illinois, United States

  • Northwestern University

    Lake Forest, Illinois, United States

  • John'S Hopkins University

    Baltimore, Maryland, United States

  • Dana Farber/partners Cancer Care Inc

    Boston, Massachusetts, United States

  • Washington University in St. Louis/ Siteman Cancer Center

    St Louis, Missouri, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

  • University of Pittsburg/ Magee-Womens Hospital

    Pittsburgh, Pennsylvania, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Estrogens, conjugated (USP)
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2017
Primary completion
19 Jun 2024
Completion
19 Jun 2024
Last update posted
28 Jan 2025
Registered enrollment
142
Registry id
NCT02694809
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.