Status:
TERMINATED
Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms
Lead Sponsor:
Carol Fabian, MD
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Focus of Study is Healthy Women at Risk for Breast Cancer
Eligibility:
FEMALE
45-60 years
Phase:
EARLY_PHASE1
Brief Summary
Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.
Detailed Description
Duavee® which is the combination of the selective estrogen receptor modulator bazedoxifene and conjugated estrogen 0.45 mg) is an FDA approved drug for treatment of hot-flashes and prevention of osteo...
Eligibility Criteria
Inclusion
- Women who report vasomotor symptoms (hot flashes or night sweats)
- No menstrual periods for at least 3 months
- Must have at least one ovary (hysterectomy is permitted; bilateral salpingo- oophorectomy is excluded).
- BMI \<36 kg/m2
- Moderate risk of developing breast cancer based on having any one or more of the following:
- First or 2nd degree relative with breast cancer
- Known carrier of moderate to high penetrance germline mutation
- Prior breast biopsy showing proliferative breast disease or multiple biopsies
- High mammographic density (Volpara® categories c or d or BIRADs density assessment as heterogeneously or extremely dense (c or d).
- IBIS Breast Cancer Risk Evaluation Version 8 10-year relative risk of \>2X that for the population for age group.
Exclusion
- Risk: A prior biopsy showing LCIS, DCIS, or invasive breast cancer.
- Medical Conditions:
- Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
- History of renal or liver disease
- Prior invasive ovarian or endometrial cancer
- Medications
- Current anticoagulant use other than low dose aspirin
- Taking systemic hormones within two months (eight weeks) prior to baseline MRI and mammogram.
- Taking tamoxifen, raloxifene, Duavee, or any selective estrogen receptor modulator, or an aromatase inhibitor within 12 months prior to baseline MRI and mammogram.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04379024
Start Date
June 1 2020
End Date
July 31 2021
Last Update
October 29 2021
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7820