Onapristone as Preoperative Treatment for Postmenopausal Women With Hormone Receptor + and HER2- Breast Cancer

Summary

ONAWA is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of onapristone (ONA) on proliferation after 3 weeks of treatment in postmenopausal women with ER+/PgR+ and HER2-negative early breast cancer amenable to pre-operative endocrine therapy and surgery.

Timeline

Start

2020-11-06

Primary completion

2021-04-30

Completion

2021-04-30

Publications

• Bellet M, Ferrero-Cafiero JM, Bergamino Sirven M, Falato C, Gonzalez X, Amillano K, Chic N, Morales S, Gasol A, Nuciforo P, Villacampa G, Villagrasa P, Diep CH, Seelig D, Lange C, D'Assoro A, Prat A, Pascual T, Saura C. Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results. NPJ Breast Cancer. 2026 May 29. doi: 10.1038/s41523-025-00887-9. Online ahead of print.

Drugs

Indications