# DAWNA-1

Source: https://onco.cc/trials/dawna-1/  
OnCo record `dawna-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that made dalpiciclib the first Chinese CDK4/6 inhibitor approved, more than doubling the time before breast cancer grew when added to fulvestrant.

## Summary

361 patients randomised 2:1. Median progression-free survival 15.7 versus 7.2 months (hazard ratio 0.42), published in Nature Medicine 2021, with neutropenia the main toxicity. NMPA approval December 2021; DAWNA-2 (first line with an aromatase inhibitor) followed in 2023. It reproduced the PALOMA-3 and MONALEESA-3 pattern with a domestic, reimbursed drug.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT03927456
- Phase: 3
- Setting: HR-positive, HER2-negative advanced breast cancer after progression on endocrine therapy, China: dalpiciclib or placebo plus fulvestrant
- Sponsor: Jiangsu Hengrui Pharmaceuticals
- Enrolled: 361
- Result: PFS 15.7 vs 7.2 months, HR 0.42.
- Outcomes: Progression-free survival: Dalpiciclib + fulvestrant 15.7 months vs Placebo + fulvestrant 7.2 months, HR 0.42

## Sources

- ClinicalTrials.gov NCT03927456: https://clinicaltrials.gov/study/NCT03927456
- Nat Med 2021: https://doi.org/10.1038/s41591-021-01562-9

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [CDK4/6 inhibitors](https://onco.cc/technologies/cdk46-inhibitor/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/)
- drugs: [Dalpiciclib](https://onco.cc/drugs/dalpiciclib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/)
- companies: [Jiangsu Hengrui Pharmaceuticals](https://onco.cc/companies/hengrui/)
- institutions: [Cancer Hospital, Chinese Academy of Medical Sciences](https://onco.cc/institutions/cams-cancer-hospital/)
- people: [Binghe Xu](https://onco.cc/people/xu-binghe/)
- key papers: [Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial](https://onco.cc/key-papers/paper-dawna-1-nat-med-2021/)

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