Pegylated liposomal doxorubicin (Duomeisu^®) monotherapy in patients with HER2-negative metastatic breast cancer heavily pretreated with anthracycline and taxanes: a single-arm, phase II study.

ABSTRACT:

Purpose

To evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) heavily pretreated with anthracycline and taxanes.

Methods

In this single-arm, phase II study, patients with HER2-negative MBC previously treated with anthracycline and taxanes as second- to fifth chemotherapy received PLD (Duomeisu^®, generic doxorubicin hydrochloride liposome) 40 mg/m² every 4 weeks until disease progression, unacceptable toxicity, or completion of six cycles. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR)

SUBMITTER: Jiang H 

PROVIDER: S-EPMC9986665 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature