Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Background: Taxane plays a key role in the treatment of breast cancer and taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect leading to treatment discontinuation. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. However, the effects of GM1 on TIPN in breast cancer patients remains unknown.

Purpose: This randomized phase III trial is designed to evaluate the potential effects of GM1 for preventing TIPN in breast cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Docetaxel; Epirubicin; Paclitaxel; Taxane

Criteria

Enrollment Criteria:

• Female patients with histologically confirmed early-stage breast cancer at the age of ≥18 and ≤75 , who have received radical surgical treatment of breast cancer (including modified radical mastectomy and breast-conserving surgery) while have not received neoadjuvant chemotherapy. EC*4-T*4 chemotherapy (T is paclitaxel or docetaxel) protocol is expected, and there is no herceptin indication or the patients are voluntarily not to be treated with herceptin.

• Patients with KPS（Karnofsky Performance Status) scores ≥ 80;

• Patients with ECOG score ≤ 1;

• Expected survival ≥ 3 months;

• The functional level of main organs must meet the following requirements (no blood transfusion, no leucocyte or platelet-ascending drugs used within 2 weeks before screening):1)Blood Routine: Neutrophil (ANC) ≥ 1.5 x 109/L;Platelets (PLT) ≥ 90 x 109/L; Hemoglobin (Hb) ≥ 90 g/L;2) Blood Biochemistry Total bilirubin (TBIL) ≤ 1.5 x ULN;L-Alanine (ALT) and aspartic transaminase (AST) ≤ 2 x ULN;Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 x ULN;

• Cooperate to complete questionnaire accurately recording occurrence and severity of neurotoxicity

• Sign the informed consent form.

Exclusion Criteria:

• There are any toxicity events of peripheral nervous system before enrollment, including: FACT-Ntx subscale score < 44;≥ Grade 1 peripheral toxicity according to CTCAE Version 4.0 rating scale;≥ Grade 1 peripheral toxicity according to ENS rating scale;All other pathological symptoms or diseases might affect the evaluation of adverse neurotoxic effects

• Patients having received other drug treatments might cause similar adverse neurotoxic effects within 4 weeks prior to the treatment of this protocol, or receive concurrent neurotoxic drugs. Including: Taxanes or analogues; Vinca alkaloids or analogues; Platinums or analogues; Cytarabine, thalidomide, bortezomib, or procarbazine; Other drugs or treatments might cause peripheral neurotoxicity

• Patients in poor general conditions, with KPS (Karnofsky performance status) scores < 80;

• Pregnant or lactating women；

• Patients (female) having the possibility of fertility but unwilling or not taking effective contraceptive measures

• Patients also having other neurological abnormalities who cannot accurately record the occurrence and severity of neurotoxicity;

• Patients known allergy to trial drugs or excipient compositions of these products;

• Patients with inherited glucose and lipid metabolism abnormalities (gangliosidosis such as amaurotic family idiocy and retinopathy);

• Patients not suitable for treatment of ganglioside;

• Active infection (depending on the judgment of investigators);

• Patients with serious concurrent diseases might harmful to safety and interfere the scheduled treatment or concomitant diseases might affect the completion of the study, depending on the judgment of investigators.

• Patients with a history of definite neurological or dysphrenia, including epilepsy or dementia.