A Multicenter, Randomized, Double-blind Phase II Trial to Evaluate GM1 Prevention of Peripheral Neuropathy in Patients With Breast Cancer

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 20, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients
Interventions
DRUG

Monosialotetrahexose ganglioside sodium injection

The treatment period was GM1/ placebo with albumin-paclitaxel from cycle 1 to cycle 4/6. The treatment period was GM1/ placebo with albumin-paclitaxel. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration.

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT05802342 - A Multicenter, Randomized, Double-blind Phase II Trial to Evaluate GM1 Prevention of Peripheral Neuropathy in Patients With Breast Cancer | Biotech Hunter | Biotech Hunter