Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer

Unknown 24 enrolled Cancer Institute and Hospital, Chinese Academy of Medical Sciences CSPC Ouyi Pharmaceutical Co., Ltd. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the dose-limiting toxicity of mitoxantrone hydrochloride liposome combined with capecitabine in patients with HER-2 negative advanced breast cancer who have received at least first-line treatment, explore the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome, and determine the recommended phase II dose (RP2D).

Timeline

Start: 2023-11-28
Primary completion: 2024-04
Completion: 2025-04

Publications

Liu J, Jiang M, Zhang M, Zhou S, Li M, Shi X, Li L, Yang X, Li P, Tian M, Ma F, Xu B, Li Q. Mitoxantrone hydrochloride liposome (Lipo-MIT) combined with capecitabine in HER2-negative advanced breast cancer: a dose-escalation, phase I study. BMC Med. 2026 Apr 28;24(1):356. doi: 10.1186/s12916-026-04895-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	825 mg/m2	Oral
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Mitoxantrone hydrochloride liposome	Unknown	16 mg/m2	Intravenous
Subject	Mitoxantrone hydrochloride liposome	Unknown	18 mg/m2	Intravenous
Subject	Mitoxantrone hydrochloride liposome	Unknown	20 mg/m2	Intravenous
Subject	Mitoxantrone hydrochloride liposome	Unknown	22 mg/m2	Intravenous

Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer

Summary

Timeline

Publications

Drugs

Indications