What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving selective estrogen receptor modulators (SERMs) like Bazedoxifene and estrogen therapies such as Conjugated Estrogens, have several known side effects. SERMs can cause hot flashes, vaginal discharge, and increase the risk of thromboembolic events like deep vein thrombosis and pulmonary embolism. Estrogen therapies, while effective in alleviating menopausal symptoms, can increase the risk of breast cancer recurrence, stroke, and thromboembolic events. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer that are similar to Bazedoxifene plus Conjugated Estrogens (BZA+CE) include selective estrogen receptor modulators (SERMs) like tamoxifen and raloxifene. Tamoxifen is used for treating and preventing estrogen receptor-positive (ER+) breast cancer, while raloxifene is approved for breast cancer prevention in postmenopausal women at high risk. Hormone replacement therapies (HRT) involving estrogens are used to manage menopausal symptoms but are used cautiously in breast cancer patients. The combination of SERMs with estrogens, as studied in the BZA+CE trial, aims to alleviate menopausal symptoms and potentially influence breast tissue biomarkers.

What other types of research exist?

Promising alternatives to Bazedoxifene plus Conjugated Estrogens for breast cancer patients include: <ol> <li>Non-hormonal therapies such as SSRIs (e.g., venlafaxine, paroxetine) for managing menopausal symptoms.</li> <li></li> </ol> Aromatase inhibitors (e.g., letrozole, anastrozole) which reduce estrogen production and are effective in hormone receptor-positive breast cancer. 3. Other SERMs like tamoxifen, which has been used for breast cancer treatment and prevention. 4. Angiogenesis inhibitors (e.g., bevacizumab) for their role in cancer treatment and potential symptom management.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baselne to 6 months

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

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

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.

0 / 11Eligibility criteria met

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.