ACTIVE_NOT_RECRUITING

Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.

Official Title

Randomized IIB Study of the Effect of Bazedoxifene Plus Conjugated Estrogens on Breast Imaging and Tissue Biomarkers in Peri or Post-Menopausal Women at Increased Risk for Development of Breast Cancer

Quick Facts

Study Start:2021-12-14
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04821141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 64 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Carol J Fabian, MD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
University of California San Francisco
San Francisco, California, 94115
United States
Northwestern Medical Center
Chicago, Illinois, 60601
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Carol J Fabian, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-14
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2021-12-14
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • breast cancer, menopausal symptoms, hot flashes

Additional Relevant MeSH Terms

  • Risk Reduction
  • Breast Cancer