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

Summary

This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens.

Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is stratified according to three factors: number of lines of previous treatment for metastatic disease (2 or 3/4 lines), receptor status (triple-negative, non-triple-negative), and visceral metastasis (yes/no).

Progression-free survival (PFS) is the main efficacy indicator in this study. Treatment Group: Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.

Control Group: Physician's Choice Group, subjects are given Eribulin Mesilate injection; or capecitabine tablets; or gemcitabine hydrochloride for injection; or vinorelbine tartrate injection; or paclitaxel (albumin-bound). Three or four weeks constitutes one cycle of treatment.

If subject does not develop disease progression after 6 cycles of dosing, the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.

Superiority design is used in this study, progression-free survival (PFS) is the main efficacy indicator. Assuming α = 0.0249(unilateral, adjusted test level), power=80%, the median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7 months, the enrollment period is 12 months, and the study period is 24 months. Using PASS (version 11.0) for calculation, a total of 152 subjects (76 in each group) are required to meet the statistical significance between the treatment group and the control group. In consideration of case expulsion, enlarged by 10%, a total of 168 subjects (84 in each group) are required.

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.

Sponsors & Collaborators

• Shanghai Yizhong Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yongmei Yin · The First Affiliated Hospital with Nanjing Medical University

• Jiong Wu · Fudan University

• Jian Zhang · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-25

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations