Phase 2
Completed N=28
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
Source: ClinicalTrials.gov NCT02729701 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Feasibility for a Larger Trial — 42; 28; 28 Participants
Summary
The purpose of this study is to learn whether daily use of Duavee® is accepted and tolerated by peri- and post-menopausal women at moderate risk for development of breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility for a Larger Trial |
42; 28; 28 | — |
| SECONDARY Change in Ki-67 |
-1.2 | 0.017 sig |
| SECONDARY Change in Fibroglandular Volume (FGV) |
-12 | 0.043 sig |
| SECONDARY Change in Body Composition (Total Mass) |
0.9 | 0.088 |
| SECONDARY Levels of Bazedoxifene in the Blood |
1.83 | — |
Eligibility Criteria
Inclusion Criteria
- Women with vasomotor symptoms with a uterus who are postmenopausal or in late menopause transition
- Body Mass Index (BMI) <36 kg/m2
- Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration (RPFNA); If Class 0 or 4, must be resolved with additional procedures
- If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones
- Confirmed moderate risk of developing breast cancer
- RPFNA results within study defined range
- Kidney and liver function within study defined range
- Willing and able to comply with study related procedures
Exclusion Criteria
- Previous biopsy showing evidence of breast cancer
- Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
- History of renal or liver disease
- Prior ovarian or endometrial cancer
- Stopped or started hormone replacement within 8 weeks
- Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA
- Currently taking or have taken specific medications in the past 6 months
- Participation on any chemoprevention trial within 6 months
- Current illness which would make potential participant unsuitable for enrollment
Data sourced from ClinicalTrials.gov (NCT02729701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.