drugset / Trial / NCT04214288
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
Timeline
- Start
- 2020-04-22
- Primary completion
- 2022-08-30
- Completion
- 2027-06-16
Outcome
Met primary endpoint
registry analysis (superiority test); AZD9833 75mg vs Fulvestrant 500 mg; p = 0.0167; Hazard Ratio (HR) 0.59 (90% CI 0.42 to 0.82); Log Rank NCT04214288 ↗
paper Camizestrant at 75 and 150 mg showed a significant benefit in progression-free survival versus fulvestrant. PMID 39481395 ↗
Publications
- Oliveira M, Pominchuk D, Nowecki Z, Hamilton E, Kulyaba Y, Andabekov T, Hotko Y, Melkadze T, Nemsadze G, Neven P, Vladimirov V, Zamagni C, Denys H, Forget F, Horvath Z, Nesterova A, Ajimi M, Kirova B, Klinowska T, Lindemann JPO, Lissa D, Mathewson A, Morrow CJ, Traugottova Z, van Zyl R, Arkania E. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol. 2024 Nov;25(11):1424-1439. doi: 10.1016/S1470-2045(24)00387-5.
- 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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camizestrant | Other / unclassified | 75 mg | Oral |
| Subject | Camizestrant | Other / unclassified | 150 mg | Oral |
| Subject | Camizestrant | Other / unclassified | 300 mg | Oral |
| Comparator | Fulvestrant | Small molecule | 500 mg | Intramuscular |