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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
Must not have
LCIS specifically designated as pleomorphic
Current anticoagulant use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baselne to 6 months
Awards & highlights

Summary

This trial tests a combination of two medications, bazedoxifene and conjugated estrogens, in women at risk for breast cancer who also have menopausal hot flashes. The treatment aims to reduce these symptoms and possibly lower cancer risk. Researchers will compare changes in breast tissue and hormone levels over several months between those taking the medication and those who are not. Bazedoxifene paired with conjugated estrogens is the first combination approved by the FDA for treating menopausal symptoms.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast condition is identified as pleomorphic LCIS.
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I am currently taking blood thinners.
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I have had both of my ovaries surgically removed.
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I have hypoparathyroidism or my triglycerides were over 300 mg/dl recently.
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I have a harmful BRCA1 or BRCA2 gene mutation.
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I have had breast, uterine, or ovarian cancer before.
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I had a high-risk ER+ or PR+ ductal carcinoma in situ.
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I have kidney or liver disease, or my blood tests for these organs show significant abnormalities.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in FGV
Secondary study objectives
Change in proliferation
Other study objectives
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include hormone therapies, chemotherapy, targeted therapies, and immunotherapy. Hormone therapies, such as selective estrogen receptor modulators (SERMs) like Bazedoxifene, work by blocking estrogen receptors on breast cancer cells, thereby inhibiting their growth. Conjugated estrogens (CE) provide estrogen to alleviate menopausal symptoms but can also influence breast tissue biomarkers, potentially affecting cancer progression. These mechanisms are crucial for breast cancer patients as they directly target the hormonal pathways that often drive the growth of hormone receptor-positive breast cancers, offering a tailored approach to treatment and symptom management.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,335 Total Patients Enrolled
22 Trials studying Breast Cancer
4,256 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,880 Total Patients Enrolled
944 Trials studying Breast Cancer
1,543,844 Patients Enrolled for Breast Cancer
Carol J Fabian, MDPrincipal InvestigatorUniversity of Kansas Medical Center
13 Previous Clinical Trials
3,966 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
~48 spots leftby Jul 2026