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Selective Estrogen Receptor Modulator (SERM)

Bazedoxifene + Conjugated Estrogens for Breast Cancer Risk Reduction

Phase 2
Recruiting
Led By Carol J Fabian, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women ages 45 - 60 or ages 61-64 if their last mammogram was described as heterogeneously or extremely dense
Current vasomotor symptoms occurring at least once a week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baselne to 6 months
Awards & highlights

Study Summary

This trial is testing whether taking a combination of bazedoxifene and conjugated estrogens for six months can help reduce risk factors for breast cancer development.

Who is the study for?
Women aged 45-64 with moderate risk of breast cancer, experiencing menopausal hot flashes at least weekly, and not currently on certain hormone treatments or having specific health conditions. Participants must have a BMI ≤ 38 kg/m2 and at least one breast assessable by Volpara software without prior radiation.Check my eligibility
What is being tested?
The trial is testing if Bazedoxifene plus Conjugated Estrogens can reduce the risk of developing breast cancer in women with vasomotor symptoms. It measures changes in fibroglandular volume and cell proliferation over six months against a control group.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with estrogen therapy such as nausea, headache, blood clots, and hormonal imbalances. Specific side effects for this combination will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 45-60, or 61-64 with a recent mammogram showing dense breast tissue.
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I experience hot flashes or night sweats at least once a week.
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I have at least one ovary.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in FGV
Secondary outcome measures
Change in proliferation
Other outcome measures
Change in blood hormones
change in gene expression

Trial Design

2Treatment groups
Experimental Treatment
Group I: Bazedoxifene plus conjugated estrogens wait listExperimental Treatment1 Intervention
No intervention for initial 6 months (wait list), then BZA (20 mg) plus CE (0.45 mg) taken together once daily for 6 months, commencing 6 months after enrollment. Optional on the part of subject.
Group II: Bazedoxifene plus conjugated estrogens immediatelyExperimental Treatment1 Intervention
BZA (20 mg) plus CE (0.45 mg) taken together once daily for 6 months, commencing immediately.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
459 Previous Clinical Trials
168,984 Total Patients Enrolled
22 Trials studying Breast Cancer
4,390 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,715 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,223 Patients Enrolled for Breast Cancer
Carol J Fabian, MDPrincipal InvestigatorUniversity of Kansas Medical Center
12 Previous Clinical Trials
3,946 Total Patients Enrolled
10 Trials studying Breast Cancer
3,919 Patients Enrolled for Breast Cancer

Media Library

Bazedoxifene (Selective Estrogen Receptor Modulator (SERM)) Clinical Trial Eligibility Overview. Trial Name: NCT04821141 — Phase 2
Breast Cancer Research Study Groups: Bazedoxifene plus conjugated estrogens wait list, Bazedoxifene plus conjugated estrogens immediately
Breast Cancer Clinical Trial 2023: Bazedoxifene Highlights & Side Effects. Trial Name: NCT04821141 — Phase 2
Bazedoxifene (Selective Estrogen Receptor Modulator (SERM)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04821141 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of the population being treated through this research study?

"As per the inclusion criteria, 120 eligible participants are needed for this trial. The two main locations open to enrolling patients are Northwestern Medical Center in Chicago and Dana Farber Cancer Institute in Boston."

Answered by AI

Has the FDA granted approval for Bazedoxifene and Conjugated Estrogens?

"Bazedoxifene and Conjugated Estrogens have been evaluated in a Phase 2 trial, so their safety is estimated to be a score of 2 on the 1-3 scale. This implies that there are some data points supporting safety but none demonstrating efficacy."

Answered by AI

How many venues are providing access to this research?

"This medical study is welcoming participants at Northwestern Medical Center in Chicago, IL; Dana Farber Cancer Institute in Boston, MA; University of Kansas Medical Center in Kansas City, KS as well as 5 other sites."

Answered by AI

To which conditions does the Bazedoxifene and Conjugated Estrogens combination provide relief?

"Bazedoxifene and Conjugated Estrogens can be utilized to alleviate premature menopause as well as other conditions such as female castration, vasomotor dysfunction, and the cessation of menses."

Answered by AI

Could you elaborate on any prior experiments that have utilized Bazedoxifene and Conjugated Estrogens?

"Bazedoxifene and Conjugated Estrogens research began in 2013 at UTMB Speciality Care Center at Victory Lakes, with 53 studies completed to date. Currently 15 active trials are taking place around the world, particularly concentrated within Chicago, Illinois."

Answered by AI

Is enrollment open for this research trial?

"According to the data on clinicaltrials.gov, this trial is presently enrolling members. This medical experiment was initially published on December 14th 2021 and its details were last modified February 14th 2022."

Answered by AI

Does this investigation permit minors to participate?

"Qualifying patients for this clinical study must be aged 45 to 60. Conversely, there are 78 trials directed at minors and an abundance of studies available (2538) for seniors over 65."

Answered by AI

Do I meet the eligibility criteria to join this research endeavor?

"This clinical trial seeks to enroll 120 patients with risk reduction, aged 45-60 years old. The inclusion criteria includes current vasomotor symptoms (hot flashes, night sweats or both) at least once a week, one of four menopausal status categories and BMI ≤ 35 kg/m2. Furthermore, participants must have an intact uterus if within age 45 - 60 and either possess an ovary or had their FSH tested as ≥ 25 mIU/ml in the postmenopausal range by institutional laboratory standards for those between ages 45-49."

Answered by AI

Who else is applying?

What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
~61 spots leftby Jul 2026