Duavee (bazedoxifene‑conjugated estrogen) to lower breast cancer risk in high‑risk women
Biomarker-Based Phase IIB Trial of (Bazedoxifene-Conjugated Estrogen) to Reduce Risk for Breast Cancer
Six months of Duavee will be given to postmenopausal women at increased breast cancer risk who have hot flashes to see whether it improves blood and breast tissue markers and mammogram density linked to risk.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Kansas Medical Center NIH-funded |
| Lab location | 1 site (Kansas City, United States) |
| Project ID | NIH-11145085 on NIH RePORTER |
What this research studies
If you are a woman at increased risk for breast cancer and have bothersome hot flashes, this multi‑center, randomized, double‑blind trial would give half of participants Duavee and half placebo for six months. Before and after treatment you would have blood tests, mammograms analyzed for fibroglandular volume (Volpara), and a sample of benign breast tissue to measure cell proliferation (Ki‑67), along with weight and quality‑of‑life questionnaires. Participants are stratified by site, mammographic density, and Ki‑67 to balance groups. The goal is to measure changes in biomarkers linked to breast cancer risk rather than to measure cancer occurrence directly.
Who could benefit from this research
Good fit: Postmenopausal women at increased risk for breast cancer who are experiencing vasomotor symptoms (hot flashes) are the ideal candidates.
Not a fit: Premenopausal women, people without hot flashes, or those with contraindications to estrogen therapy (such as a history of estrogen‑sensitive cancer or thromboembolic disease) are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, Duavee could both relieve hot flashes and lower biomarkers associated with breast cancer risk, making a prevention option more acceptable to women.
How similar studies have performed: A small pilot showed Duavee reduced hot flashes and improved mammographic and tissue biomarkers, but larger randomized evidence is still needed.
Where this research is happening
Kansas City, United States
- University of Kansas Medical Center — Kansas City, United States (Active)
Researchers
- Principal investigator: Fabian, Carol J. — University of Kansas Medical Center
- Study coordinator: Fabian, Carol J.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.