Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

September 25, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Metastatic Breast Cancer (MBC)
Interventions
DRUG

Paclitaxel Polymeric Micelles for Injection

Subjects are given 300 mg/m2 of Paclitaxel Polymeric Micelles for Injection without special infusion device,intravenously administrated for ≥ 3 hours.Three weeks constituted one course of treatment.

DRUG

Eribulin Mesilate injection

Subjects are given 1.4 mg/m2 of Eribulin Mesilate injection on days 1 and 8 of the 21-day cycle.

DRUG

Capecitabine Tablets

Subjects are given 1000-1250mg/m2 of Capecitabine Tablets on days 1 to 14 of the 21-day cycle ,and twice a day (once in the morning and once in the evening; Total daily dose 2000-2500mg/m2).

DRUG

Gemcitabine Hydrochloride for Injection

Subjects are given 800-1200mg/m2 of Gemcitabine Hydrochloride for Injection on days 1, 8 and 15 of the 28-day cycle.

DRUG

Vinorelbine Tartrate Injection

Subjects are given 25mg/m2 of Vinorelbine Tartrate Injection every first day of the week.

DRUG

Paclitaxel (albumin-bound)

Subjects are given 260mg/m2 of Paclitaxel (albumin-bound) on day 1 of the 21-day cycle,intravenous administration for more than 30 minutes.

Trial Locations (3)

201321

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

210029

RECRUITING

Jiangsu province Hospital, Nanjing

All Listed Sponsors
lead

Shanghai Yizhong Pharmaceutical Co., Ltd.

INDUSTRY