Clinical trial · Interventional
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation
Pilot Study of the Effect of Duavee® on Benign Breast Tissue Proliferation in Peri or Post-menopausal Women at Moderate Risk for Development of Breast Cancer
NCT02729701CI-TRIAL-00056983completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duavee | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Duavee
- description
- Participants will be asked to take Duavee for 6 months while on the study.
- interventionNames
- Drug: Duavee
Primary outcomes (1)
- measure
- Feasibility for a Larger Trial
- timeFrame
- 6 Months
- description
- Outcome will be based on three separate factors used collectively to determine feasibility of the study and consideration of a subsequent larger trial. These are accrual rate (ability to accrue target number of subjects in a timely manner), dropout rate (frequency of subjects who are compliant and complete the intervention) and change in Ki-67 (increase vs decrease in percent of cells stained positive in the majority of subjects). Should accrual be inadequate or too slow; or if retention is too low; then a decision would be made not to proceed to a larger trial. Also, if there is evidence of an increase in proliferation (Ki-67) then no further studies would be planned.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 61 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFabian CJ, Nye L, Powers KR, Nydegger JL, Kreutzjans AL, Phillips TA, Metheny T, Winblad O, Zalles CM, Hagan CR, Goodman ML, Gajewski BJ, Koestler DC, Chalise P, Kimler BF. Effect of Bazedoxifene and Conjugated Estrogen (Duavee) on Breast Cancer Risk Biomarkers in High-Risk Women: A Pilot Study. Cancer Prev Res (Phila). 2019 Oct;12(10):711-720. doi: 10.1158/1940-6207.CAPR-19-0315. Epub 2019 Aug 16. PMID 31420361