Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase.

ABSTRACT:

Purpose

Metastatic breast cancer (mBC) remains incurable and is associated with low survival rates. This study assessed the efficacy and safety of liposomal irinotecan in heavily pretreated patients with mBC, with or without active brain metastases (BM).

Methods

Following the dose escalation phase and determination of recommended phase 2 dose, the expansion phase of this phase I, open-label, non-randomized study, assigned adult women to cohorts based on mBC subtype: cohort 1, hormone receptor +/human epidermal growth factor receptor 2-; cohort 2, triple-negative breast cancer; or cohort 3, any mBC subtype with active BM. Patients received liposomal irinotecan 50 or 70 mg/m² free base every 2 weeks. Here, we report secondary outcomes including best overall response

SUBMITTER: Sachdev JC 

PROVIDER: S-EPMC7921078 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature