Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biomarkers in High-Risk Women: A Pilot Study.
Cancer Prev Res (Phila)
; 12(10): 711-720, 2019 10.
Article
in En
| MEDLINE
| ID: mdl-31420361
ABSTRACT
Interventions that relieve vasomotor symptoms while reducing risk for breast cancer would likely improve uptake of chemoprevention for perimenopausal and postmenopausal women. We conducted a pilot study with 6 months of the tissue selective estrogen complex bazedoxifene (20 mg) and conjugated estrogen (0.45 mg; Duavee) to assess feasibility and effects on risk biomarkers for postmenopausal breast cancer. Risk biomarkers included fully automated mammographic volumetric density (Volpara), benign breast tissue Ki-67 (MIB-1 immunochemistry), and serum levels of progesterone, IGF-1, and IGFBP3, bioavailable estradiol and testosterone. Twenty-eight perimenopausal and postmenopausal women at increased risk for breast cancer were enrolled 13 in cohort A with baseline Ki-67 < 1% and 15 in cohort B with baseline Ki-67 of 1% to 4%. All completed the study with > 85% drug adherence. Significant changes in biomarkers, uncorrected for multiple comparisons, were a decrease in mammographic fibroglandular volume (P = 0.043); decreases in serum progesterone, bioavailable testosterone, and IGF-1 (P < 0.01), an increase in serum bioavailable estradiol (P < 0.001), and for women from cohort B a reduction in Ki-67 (P = 0.017). An improvement in median hot flash score from 15 at baseline to 0 at 6 months, and menopause-specific quality-of-life total, vasomotor, and sexual domain scores were also observed (P < 0.001). Given the favorable effects on risk biomarkers and patient reported outcomes, a placebo-controlled phase IIB trial is warranted.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Vasomotor System
/
Breast Neoplasms
/
Biomarkers, Tumor
/
Estrogens, Conjugated (USP)
/
Breast Density
/
Indoles
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Risk_factors_studies
Aspects:
Patient_preference
Limits:
Aged
/
Female
/
Humans
/
Middle aged
Language:
En
Journal:
Cancer Prev Res (Phila)
Journal subject:
NEOPLASIAS
Year:
2019
Document type:
Article