Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control
Accrual initiation was delayed due to contractual difficulties surrounding BZA importation during COVID-19 and deploying a fully automated method (Volpara®) to assess the primary endpoint. To accommodate this delay, a mid-grant no cost extension along with amended eligibility requirements were employed. 61/120 participants needed were entered in the initial 27 months of accrual and 37 months of funding. Despite a late start, accrual is likely to be completed within the funding period.
Authors
- Lauren Nye (ORCID: https://orcid.org/0000-0001-6921-0987)
- Byron J. Gajewski (ORCID: https://orcid.org/0000-0001-7589-8247)
- Judy Ellen Garber (ORCID: https://orcid.org/0000-0001-9449-3982)
- Krystal Pittman
- Kate Young
- Xuhui Lee (ORCID: https://orcid.org/0000-0003-1350-4446)
- Amy L. Kreutzjans
- Dinesh Pal Mudaranthakam (ORCID: https://orcid.org/0000-0001-9767-1158)
- Christy Altman
- Kandy R. Powers
- Adrian Zelenchuk
- Bruce F. Kimler (ORCID: https://orcid.org/0000-0001-7021-6964)
- Carol J. Fabian (ORCID: https://orcid.org/0000-0002-8855-4133)
- Trina Metheny
- Laura J. Esserman (ORCID: https://orcid.org/0000-0001-9202-4568)
- Seema A. Khan (ORCID: https://orcid.org/0000-0002-6307-2023)
- Lori Ranallo
- Onalisa Winblad (ORCID: https://orcid.org/0000-0003-3560-2813)
- Barry S. Komm
Institutions
- Northwestern University (US)
- University of California, San Francisco (US)
- City of Hope (US)
- Dana-Farber Cancer Institute (US)
- University of Kansas Medical Center (US)
Publication Details
- Journal
- Contemporary Clinical Trials
- Published
- 2024-09-17
- DOI
- https://doi.org/10.1016/j.cct.2024.107697
- Primary Topic
- Estrogen and related hormone effects
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Breast Cancer Research Foundation
- Division of Cancer Prevention, National Cancer Institute
- National Institutes of Health
- National Cancer Institute