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

Recruiting Phase 3 Interventional Study
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
352 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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;…
Contacts

ZeFei Jiang, Chief Physician

010-66947175

jzf_cscobc@csco.org.cn

CONTACT