GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent form;

Age: 18 to 75 years old;

Female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with Albumin paclitaxel regimens;

ECOG: 0-1

Disqualifiers

Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT/GOG-Ntx ≥1;

There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).

History of another malignant tumors (except breast cancer)

Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;

Trial design

Treatments tested in this trial

  • GM1
  • Placebo

Treatment groups

352 Participants
are divided into 2 treatment groups

Sponsors and collaborators