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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of potential participants who consent to enrollment
Secondary outcome measures
Change in breast background parenchymal enhancement (BPE)
Change in fibroglandular volume (FGV)
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.
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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
12 Previous Clinical Trials
4,050 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 45-49, had a hysterectomy or endometrial ablation, and my FSH level is 25 mIU/ml or higher.I started hormone therapy after my initial tests but before being assigned to a treatment group.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.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.I have a history of cancer.I have had a condition where my lymphocytes grow abnormally.I have a history of kidney or liver disease.I haven't had any cancer except for skin cancer in the last 5 years.I have had ovarian or endometrial cancer before.You have not had a period for at least 60 days.I am between 45 and 65 years old.My biopsy showed I have a specific type of breast cancer.You weigh less than 36 kilograms for every square meter of your height.I have been taking hormones for the last two months.I have been taking hormone therapy for breast cancer within the last year.I experience hot flashes or night sweats.I have a history or risk of blood clots or stroke.I am at moderate risk for breast cancer due to certain risk factors.
Research Study Groups:
This trial has the following groups:- Group 1: Bazedoxifene plus conjugated estrogens wait list
- Group 2: Bazedoxifene plus conjugated estrogens immediately
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for participation in this research endeavor?
"Affirmative. The details on clinicaltrials.gov reveals that this medical experiment, which was initially published on December 2nd 2021, is still recruiting patients. Currently, 20 individuals need to be enrolled from 1 research centre."
Answered by AI
Are elderly individuals within the scope of this clinical experiment?
"To be considered for this clinical trial, the minimum age requirement is 45 years old and the maximum age cutoff is 65."
Answered by AI
To what extent has the combination of bazedoxifene and conjugated estrogens been studied in research settings?
"Currently, 15 studies are underway to research bazedoxifene plus conjugated estrogens with one in its final phase. Of the 31 trial sites involved, most are located around Boston."
Answered by AI
What is the capacity of participants for this clinical investigation?
"Affirmative. Clinicaltrials.gov data suggests that this trial, created on December 2nd 2021, is still actively enrolling participants. Twenty patients need to be acquired from 1 medical centre."
Answered by AI
What conditions is the combination of bazedoxifene and conjugated estrogens employed to address?
"Bazedoxifene plus conjugated estrogens is an effective intervention for premature menopause and can also aid in the treatment of female castration, vasomotor systems, and post-menopausal symptoms."
Answered by AI
What qualifications do participants need to fulfill in order to join this research experiment?
"Breast cancer patients between the ages of 45 and 65 are eligible to partake in this research trial. Up to 20 individuals will be accepted into the study."
Answered by AI
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