Bazedoxifene + Conjugated Estrogens for Breast Cancer Risk

Overseen By Amy L Kreutzjans

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Carol Fabian, MD

Must not be taking: Systemic hormones, Tamoxifen, Raloxifene, others

Disqualifiers: Thromboembolism, Stroke, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Carol J Fabian, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for women aged 45-65 with a BMI under 36, experiencing menopause symptoms, and at moderate risk of breast cancer. They must not have had periods for at least 60 days or have high FSH levels if younger with prior hysterectomy. Participants should be willing to undergo blood tests, mammograms, MRI scans and can't have a history of certain cancers or be on hormone treatments recently.

Inclusion Criteria

Able to understand and sign an informed consent form for screening and for intervention

I am a woman aged 45-49, had a hysterectomy or endometrial ablation, and my FSH level is 25 mIU/ml or higher.

If you want to have the optional RPFNA procedure, you need to meet the criteria for participating in the HSC4601 study about breast tissue risk assessment.

Exclusion Criteria

I started hormone therapy after my initial tests but before being assigned to a treatment group.

I have not received BZA+CE within 3 months before my baseline MRI.

My mammogram or MRI showed possible cancer signs, but any recommended biopsy was not cancerous.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bazedoxifene plus conjugated estrogens for 6 months

6 months

Baseline and 6-month visits for MRI and mammogram assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bazedoxifene
• Conjugated Estrogens

Trial Overview The study is testing the combination of bazedoxifene and conjugated estrogens over six months to see how it affects breast MRI parameters in women who are at an increased risk for developing breast cancer but do not currently have it.

Participant Groups

Group I: Bazedoxifene plus conjugated estrogens wait list Experimental Treatment 1 Intervention

After a 6-month waiting period, receipt of 6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.

Group II: Bazedoxifene plus conjugated estrogens immediately Experimental Treatment 1 Intervention

Immediate receipt of 6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.

Bazedoxifene is already approved in United States, European Union for the following indications:

Approved in United States as Duavee for:

• Moderate to severe vasomotor symptoms associated with menopause
• Prevention of postmenopausal osteoporosis

Approved in European Union as Duavive for:

• Treatment of estrogen deficiency symptoms in postmenopausal women with an intact uterus
• Prevention of osteoporosis in postmenopausal women at high risk of future fractures

Who Is Running the Clinical Trial?

Carol Fabian, MD

Lead Sponsor

Trials

16

Recruited

4,100+