Dalpiciclib combined with pyrotinib and endocrine therapy in women with ER-positive, HER2-positive advanced breast cancer: A prospective, multicenter, single-arm, phase 2 trial.

ABSTRACT:

Background

Combination of HER2-targeted therapy and endocrine therapy offers a more tolerable alternative to HER2-targeted chemotherapy regimens for estrogen receptor (ER)-positive, HER2-positive advanced breast cancer (ABC), but with compromised efficacy. The addition of cyclin-dependent kinase 4/6 (CDK4/6) inhibition may enhance the durability of anti-tumor responses, offering a potential chemotherapy-sparing alternative, although its role in the frontline setting remains uncertain. We performed a multicenter, single-arm, phase 2 clinical trial (PLEASURABLE) to assess the activity and safety of combining dalpiciclib with pyrotinib and endocrine therapy in patients receiving first- or second-line treatment for ER-positive and HER2-positive ABC.

Methods and findings

We enrol

SUBMITTER: Zhang J 

PROVIDER: S-EPMC12312931 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature