DAWNA-1

NCT03927456 📎

Regimen

Experimental
Dalpiciclib (SHR6390) 125 mg QD (3 weeks on / 1 week off) + fulvestrant 500 mg IM.
Control
Placebo + fulvestrant 500 mg IM.

Population

HR+/HER2- advanced breast cancer with disease progression on prior endocrine therapy; pre- and postmenopausal women enrolled across China.

Key finding

DAWNA-1 established dalpiciclib (first Chinese-developed CDK4/6 inhibitor) plus fulvestrant as 2L option for HR+/HER2- MBC progressing on prior endocrine therapy. NMPA approved December 2021. PFS benefit magnitude consistent with global PALOMA-3/MONARCH-2.

Source: PMID 34737452

Timeline

  • Publication: 2021 Nov

Guideline citations

  • NCCN BREAST