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Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 29, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 5 to 6v12 Show 1 more changeShow less
    • Study sites: 5 to 6
  2. Re-verified, no change to tracked fieldsv11
  3. Eligibility criteria expanded, about 133 words Site contacts updated at 4 of 5 sitesv10 Show 1 more changeShow less
    • Site contacts updated at 4 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Completion date: Jan 31, 2027 to Jul 31, 2027v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Aug 1, 2025 to Jul 31, 2026 Completion date: Jan 31, 2026 to Jan 31, 2027 · Eligibility criteria shortened, about 43 words · Site details revised at 4 of 5 sites · 1 morev7 Show 4 more changesShow less
    • Completion date: Jan 31, 2026 to Jan 31, 2027
    • Eligibility criteria shortened, about 43 words
    • Site details revised at 4 of 5 sites
    • Publications: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv6
  3. Primary completion date: Aug 2025 to Aug 1, 2025 Completion date: Dec 2025 to Jan 31, 2026 · Start date: Dec 2, 2021 to Dec 14, 2021v5 Show 2 more changesShow less
    • Completion date: Dec 2025 to Jan 31, 2026
    • Start date: Dec 2, 2021 to Dec 14, 2021
  4. Primary completion date: Aug 1, 2025 to Aug 2025 Completion date: Dec 31, 2025 to Dec 2025 · Eligibility criteria expanded, about 86 words · Site contacts updated at 1 of 5 sitesv4 Show 3 more changesShow less
    • Completion date: Dec 31, 2025 to Dec 2025
    • Eligibility criteria expanded, about 86 words
    • Site contacts updated at 1 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 4 to 5 · Primary completion date: Jul 2025 to Aug 1, 2025 · Completion date: Dec 2026 to Dec 31, 2025 · 1 morev3 Show 4 more changesShow less
    • Study sites: 4 to 5
    • Primary completion date: Jul 2025 to Aug 1, 2025
    • Completion date: Dec 2026 to Dec 31, 2025
    • Start date changed from estimate of Dec 2021 to Dec 2, 2021
  6. Start date: Jul 2021 to Dec 2021 Completion date: Jan 2026 to Dec 2026v2 Show 1 more changeShow less
    • Completion date: Jan 2026 to Dec 2026
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04821141
Lead Sponsor University of Kansas Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Risk Reduction, Breast Cancer
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov