Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

What this trial studies

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.

Conditions in scope

• Risk Reduction
• Breast Cancer

Interventions

• Bazedoxifene and Conjugated Estrogens (Drug) — BZA (20 mg) plus CE (0.45 mg) taken together once daily

Who can join

Women only · Ages 45 Years to 64 Years · Accepts healthy volunteers.

Inclusion criteria

• Current vasomotor symptoms (hot-flashes, night sweats or both). These do not need to be frequent or severe but should occur at least once a week. Women who feel that they would likely need a supplement or be at high risk of withdrawal if they were randomized to waitlist because of vasomotor symptoms are not good candidates for this trial.
• Women must be in one of the four menopausal status categories, as defined below.
• Age 45-64 with an intact uterus and no periods in past 12 months. Amenorrhea is not thought to be due to endometrial ablation, Mirena IUD or other menses suppressing contraceptives. Category 1: Clinically Postmenopausal
• Age 45-64 with an intact uterus and no periods in past 2 months immediately preceding eligibility testing; but has not been amenorrheic for 12 months. Amenorrhea not thought to be due to endometrial ablation, Mirena IUD or other menses suppressing contraceptives. Category 2: Late menopause transition.
• Age 50-64 and prior hysterectomy, prior endometrial ablation with subsequent lack of periods, or menses suppression due to Mirena IUD or other types of contraceptives. Category 3: Menopause transition by symptoms; uterus not intact or menses suppression; age ≥50.
• Age 45-49 and prior hysterectomy, prior endometrial ablation with subsequent lack of periods, or menses suppression due to Mirena IUD or other types of contraceptives. Category 4: Menopause transition by symptoms uterus not intact or menses suppression; age 45-49.
• Must have at least one ovary.
• BMI: ≤ 38 kg/m2

Exclusion criteria

• Conditions:
• Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, stroke, or myocardial infarction. Note that individuals with a prior septic embolus only with no evidence of a clotting disorder are not excluded if cleared by their cardiologist or internist.
• Prior bilateral oophorectomy
• BRCA1/2 deleterious mutation
• LCIS specifically designated as pleomorphic in the pathology report
• Prior high-risk ER+ and/or PR+ DCIS, defined as high grade, \> 2 cm in diameter or diagnosed at age \< 50.
• Prior DCIS with cancer cells at inked margin where there was not an additional resection.
• Prior invasive breast cancer

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2021-12-14
• Primary completion: 2026-07-31
• Last update posted: 2025-10-29
• First posted: 2021-03-29

Sponsor & contact

Lead sponsor: University of Kansas Medical Center (Other)

Collaborators: National Cancer Institute (NCI)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in FGV (baseline to 6 months)
  Change in fibroglandular volume assessed on 3-D digital mammogram by Volpara software.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.