A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer

Summary

This is a randomised, open-label, parallel-group, pre-surgical study aimed to investigate the biological effects, safety, tolerability, and pharmacokinetics (PK) of different doses of oral AZD9833 in post-menopausal women with primary breast cancer

Timeline

Start

2020-11-02

Primary completion

2023-06-19

Completion

2023-06-19

Publications

• Robertson JFR, Gogitidze T, Katashvili Z, Rocha JEB, Arkania E, Moppett I, Cheung KL, Nemsadze G, Ajimi M, Klinowska T, Lindemann JPO, Mathewson A, Morrow CJ, Nikolaou M, Scaltriti M, Sykes A, Dzagnidze G. Pharmacodynamics of Camizestrant Treatment in Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer: Results From the Randomized, Presurgical SERENA-3 Study. J Clin Oncol. 2026 Mar 20;44(9):750-761. doi: 10.1200/JCO-25-01548. Epub 2026 Jan 16.
• Hamilton E, Oliveira M, Turner N, Garcia-Corbacho J, Hernando C, Ciruelos EM, Kabos P, Ruiz-Borrego M, Armstrong A, Patel MR, Vaklavas C, Twelves C, Boni V, Incorvati J, Brier T, Gibbons L, Klinowska T, Lindemann JPO, Morrow CJ, Sykes A, Baird RD. A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results. Ann Oncol. 2024 Aug;35(8):707-717. doi: 10.1016/j.annonc.2024.04.012. Epub 2024 May 8.

Drugs

Indications