Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers

What this trial studies

Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters.

Conditions in scope

• Increased Risk for Development of Breast Cancer

Interventions

• bazedoxifene plus conjugated estrogens (Drug) — 6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.

Who can join

Women only · Ages 45 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Women who report vasomotor symptoms (hot flashes or night sweats or both).
• No menstrual periods for at least 60 days.
• Age 45-65. Women age 45-49 with prior hysterectomy or endometrial ablation with rare or no periods due to ablation must have a Follicle Stimulating Hormone (FSH) of 25 mIU/ml or higher to be eligible.
• BMI \<36 kg/m2
• Risk Factors/Level. Moderate risk of developing breast cancer based on either by having any one or more of the following:
• First or 2nd degree relative with breast cancer
• Known carrier of moderate to high penetrance germline mutation
• Prior breast biopsy showing proliferative breast disease or multiple prior biopsies

Exclusion criteria

• Risk: A prior biopsy showing pleomorphic lobular or ductal carcinoma in situ or invasive breast cancer.
• Medical Conditions:
• Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
• History of renal or liver disease
• Prior invasive ovarian or endometrial cancer
• Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for BZA+CE.
• Medications
• Taking systemic hormones within two months (eight weeks) prior to baseline MRI and mammogram.

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: Completed
• Study type: Interventional
• Phase: EARLY_PHASE1
• Start date: 2021-12-02
• Primary completion: 2024-05-20
• Last update posted: 2025-10-29
• First posted: 2021-03-29

Sponsor & contact

Lead sponsor: Carol Fabian, MD (Other)

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

• Number of potential participants who consent to enrollment (Enrollment)
  Trial design is acceptable to potential subjects, as evidenced by participation

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