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Bazedoxifene + Conjugated Estrogens for Breast Cancer Risk Reduction
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My breast condition is identified as pleomorphic LCIS.My kidney and liver tests are within normal ranges.I am currently taking blood thinners.I am a woman aged 45-60, or 61-64 with a recent mammogram showing dense breast tissue.I have used hormone pills or patches in the last two months.I have had both of my ovaries surgically removed.I have not taken any systemic hormones for at least 8 weeks.I experience hot flashes or night sweats at least once a week.I have hypoparathyroidism or my triglycerides were over 300 mg/dl recently.I have a harmful BRCA1 or BRCA2 gene mutation.I am at moderate risk for breast cancer.I started hormone replacement therapy after my last mammogram but before joining this study.I am currently using low dose vaginal hormones.I have at least one ovary.I have had breast, uterine, or ovarian cancer before.I have taken tamoxifen, raloxifene, or an aromatase inhibitor in the last 6 months.I had a high-risk ER+ or PR+ ductal carcinoma in situ.I have kidney or liver disease, or my blood tests for these organs show significant abnormalities.
- Group 1: Bazedoxifene plus conjugated estrogens wait list
- Group 2: Bazedoxifene plus conjugated estrogens immediately
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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."
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