ArticleNPJ breast cancer2026
Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results.
Article in NPJ breast cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04142892 (A Window of Opportunity Trial of Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor-Positive and HER2-negative Breast Cancer), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Window of Opportunity Trial of Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor-Positive and HER2-negative Breast Cancer
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Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Onapristone, a type-1 antiprogestin, has been tested for advanced breast cancer (BC), but its activity in early-stage, hormone receptor-positive, HER2-negative BC has not been fully explored. The ONAWA trial (ClinicalTrials.gov ID: NCT04142892- Registered on January 6, 2021) was a single-arm study evaluating the preoperative effects of onapristone with extended-release formulation (ONA-XR) (50 mg BID for 21 days) in postmenopausal women with Progesterone Receptor-positive (PgR+)/HER2-negative early BC. No complete cell cycle arrest (CCCA) was achieved at day 21, however ONA-XR significantly suppressed tumor proliferation with a Ki-67 geometric mean change of -17.78% (CI95 -39.76% to 12.20%) particularly in tumors with baseline PgR≥90% (-46.21%; CI -63.02% to -21.76%). Immunohistochemistry showed suppression of phospho-Ser294-PgR and p-STAT3, indicating effects on proliferation and endocrine pathways. Treatment also induced a shift to a more endocrine-sensitive phenotype. Of the 10 patients, 60% experienced adverse events, including one grade 3 increase in gamma-glutamyltransferase. In conclusion, ONA-XR showed early tumor proliferation suppression, particularly in high PgR-expressing tumors, supporting its potential for further clinical evaluation.
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