Abstract | PURPOSE: METHODS: Women aged 18-39 were randomized 1:1 to ulipristal 10-mg daily or to a combination oral contraceptive (COC) for 84 days. Participants underwent a breast biopsy and breast MRI at baseline and at end of study treatment. Proliferation of breast TDLU cells was evaluated by Ki67 immunohistochemical stain. We evaluated the breast MRIs for background parenchymal enhancement (BPE). All slides and images were masked for outcome evaluation. RESULTS: Twenty-eight treatment-compliant participants completed the study; 25 of whom had evaluable Ki67 results at baseline and on-treatment. From baseline to end of treatment, Ki67 % positivity (Ki67%+) decreased a median of 84% in the ulipristal group (N = 13; 2-sided p (2p) = 0.040) versus a median increase of 8% in the COC group (N = 12; 2p = 0.85). Median BPE scores decreased from 3 to 1 in the ulipristal group (p = 0.008) and did not decrease in the COC group. CONCLUSION: TRIAL REGISTRATION: NCT02922127, 4 October 2016.
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Authors | Carolyn L Westhoff, Hua Guo, Zhong Wang, Hanina Hibshoosh, Margaret Polaneczky, Malcolm C Pike, Richard Ha |
Journal | Breast cancer research and treatment
(Breast Cancer Res Treat)
Vol. 192
Issue 2
Pg. 321-329
(Apr 2022)
ISSN: 1573-7217 [Electronic] Netherlands |
PMID | 35015210
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. |
Chemical References |
- Norpregnadienes
- Receptors, Progesterone
- Progesterone
- ulipristal acetate
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Topics |
- Adolescent
- Adult
- Breast Neoplasms
(drug therapy)
- Cell Proliferation
- Female
- Humans
- Leiomyoma
- Norpregnadienes
- Progesterone
- Receptors, Progesterone
- Young Adult
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