← Back to Search

Selective Estrogen Receptor Modulator (SERM)

Bazedoxifene + Conjugated Estrogens for Breast Cancer Risk

Phase < 1
Waitlist Available
Led By Carol J Fabian, MD
Research Sponsored by Carol Fabian, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Age 45-65
Must not have
History of active malignancy
History of any lymphoproliferative disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a combination of two drugs, bazedoxifene and conjugated estrogens, can change breast MRI parameters.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include those commonly associated with estrogen therapy such as nausea, headache, dizziness, stomach cramps; however specific side effects related to this drug combination will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 45-49, had a hysterectomy or endometrial ablation, and my FSH level is 25 mIU/ml or higher.
Select...
I am between 45 and 65 years old.
Select...
I experience hot flashes or night sweats.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of cancer.
Select...
I have had a condition where my lymphocytes grow abnormally.
Select...
I have a history of kidney or liver disease.
Select...
I have had ovarian or endometrial cancer before.
Select...
My biopsy showed I have a specific type of breast cancer.
Select...
I have a history or risk of blood clots or stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of potential participants who consent to enrollment
Secondary study objectives
Change in breast background parenchymal enhancement (BPE)
Change in fibroglandular volume (FGV)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Bazedoxifene plus conjugated estrogens wait listExperimental Treatment1 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 immediatelyExperimental Treatment1 Intervention
Immediate receipt of 6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.

Find a Location

Who is running the clinical trial?

Carol Fabian, MDLead Sponsor
15 Previous Clinical Trials
4,052 Total Patients Enrolled
Carol J Fabian, MDPrincipal InvestigatorUniversity of Kansas Medical Center
13 Previous Clinical Trials
4,070 Total Patients Enrolled

Media Library

Bazedoxifene (Selective Estrogen Receptor Modulator (SERM)) Clinical Trial Eligibility Overview. Trial Name: NCT04821375 — Phase < 1
Increased Risk Breast Cancer Research Study Groups: Bazedoxifene plus conjugated estrogens wait list, Bazedoxifene plus conjugated estrogens immediately
Increased Risk Breast Cancer Clinical Trial 2023: Bazedoxifene Highlights & Side Effects. Trial Name: NCT04821375 — Phase < 1
Bazedoxifene (Selective Estrogen Receptor Modulator (SERM)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04821375 — Phase < 1
~4 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top