Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens (NCT04821141) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
United States120 participantsStarted 2021-12-14
Plain-language summary
Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.
Who can participate
Age range45 Years – 64 Years
SexFEMALE
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Inclusion Criteria for Baseline Mammogram and RPFNA Women ages 45 - 60 or ages 61-64 if their last mammogram was described as heterogeneously or extremely dense.
Current vasomotor symptoms (hot-flashes, night sweats or both). These do not need to be frequent or severe but should occur at least once a week. Women who feel that they would likely need a supplement or be at high risk of withdrawal if they were randomized to waitlist because of vasomotor symptoms are not good candidates for this trial.
Women must be in one of the four menopausal status categories, as defined below.
* Age 45-64 with an intact uterus and no periods in past 12 months. Amenorrhea is not thought to be due to endometrial ablation, Mirena IUD or other menses suppressing contraceptives. Category 1: Clinically Postmenopausal
* Age 45-64 with an intact uterus and no periods in past 2 months immediately preceding eligibility testing; but has not been amenorrheic for 12 months. Amenorrhea not thought to be due to endometrial ablation, Mirena IUD or other menses suppressing contraceptives. Category 2: Late menopause transition.
* Age 50-64 and prior hysterectomy, prior endometrial ablation with subsequent lack of periods, or menses suppression due to Mirena IUD or other types of contraceptives. Category 3: Menopause transition by symptoms; uterus not intact or menses suppression; age ≥50.
* Age 45-49 and prior hysterectomy, prior endometrial ablation with subsequent lack of periods, or menses suppression du…