Clinical trial · Interventional
Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms
Pilot Study of Effects of Duavee® on Imaging and Blood Biomarkers In Women With Menopausal Symptoms at Increased Risk for Breast Cancer
NCT04379024CI-TRIAL-00054769terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study agent no longer available
Summary
Brief summary (as posted)
Pilot study to test feasibility of 6 months of Duavee® vs wait-list control in post-menopausal women symptomatic for hot flashes.
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 |
|---|---|---|---|
| Focus of Study is Healthy Women at Risk for Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DUAVEE 0.45Mg-20Mg Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate active agent
- description
- Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg)
- interventionNames
- Drug: DUAVEE 0.45Mg-20Mg Tablet
- type
- OTHER
- label
- Delayed active agent
- description
- No intervention for first 6 months. Then option to receive daily Duavee for 6 months.
- interventionNames
- Drug: DUAVEE 0.45Mg-20Mg Tablet
Primary outcomes (1)
- measure
- Number of potential participants who consent to enrollment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (1)
- BACKGROUNDFabian 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