Prevention of sacituzumab govitecan-related neutropenia and diarrhea in patients with HER2-negative advanced breast cancer (PRIMED): an open-label, single-arm, phase 2 trial.

ABSTRACT:

Background

Neutropenia and diarrhea are common sacituzumab govitecan-related adverse events, frequently leading to treatment modifications. PRIMED evaluated primary prophylactic granulocyte colony-stimulating factor (G-CSF) and loperamide to improve sacituzumab govitecan tolerability.

Methods

PRIMED (NCT05520723) was an open-label, single-arm, phase II study that enrolled HER2-negative advanced breast cancer patients previously treated with 1-2 chemotherapy regimens for metastatic disease. Patients with hormone receptor positive tumors previously received CDK4/6 inhibitor in the advanced setting. Sacituzumab govitecan was administered until disease progression or unacceptable toxicity. G-CSF (5 MU/kg/day) and loperamide (2 mg/twice a day or 4 mg/day) were given during the fi

SUBMITTER: Perez-Garcia JM 

PROVIDER: S-EPMC12221278 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature