DAWNA-2

NCT03966898 📎

Regimen

Experimental
Dalpiciclib 125 mg daily (3/1) plus letrozole 2.5 mg or anastrozole 1 mg daily.
Control
Placebo plus letrozole 2.5 mg or anastrozole 1 mg daily.

Population

Chinese women with HR+/HER2- advanced breast cancer and no prior systemic therapy for advanced disease (1L); endocrine-sensitive.

Key finding

DAWNA-2 established the China-developed CDK4/6 inhibitor dalpiciclib plus AI as a 1L option for HR+/HER2- metastatic breast cancer in Chinese patients, with a PFS magnitude comparable to global CDK4/6 pivotal trials. NMPA approved dalpiciclib in 2021 (2L) and 2023 (1L) based on DAWNA-1 and DAWNA-2.

Source: PMID 37182538

Timeline

  • Publication: 2023 Jun

Guideline citations

  • NCCN BREAST