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<p>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.</p>

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Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月29日

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  • Meritxell Bellet,
  • Juan M. Ferrero-Cafiero,
  • Milana Bergamino Sirvén,
  • Claudette Falato,
  • Xavier González,
  • Kepa. Amillano,
  • Nuria Chic,
  • Serafin Morales,
  • Ariadna Gasol,
  • Paolo Nuciforo,
  • Guillermo Villacampa,
  • Patricia Villagrasa,
  • Caroline H. Diep,
  • Davis Seelig,
  • Carol Lange,
  • Antonio D’Assoro,
  • Aleix Prat,
  • Tomás Pascual,
  • Cristina Saura

摘要

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.