Taxane Induced Peripheral Neuropathy in Chinese Patients With Breast Cancer

• Conditions: Breast Cancer
• Interventions: Other: Patient Questionnaires; Other: Blood Collection

• Registration Number: NCT04068090
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to collect clinical data, blood samples, and self reported symptoms of peripheral neuropathy from Chinese patients with breast cancer after treatment with taxanes. This data will be used to develop predictive markers for neuropathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study Start: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Diagnosis of breast cancer
• Females aged 16 and older
• Planning to receive or previous treated with taxanes

Exclusion Criteria

• Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CIPN	Patient Questionnaires	Patients with peripheral neuropathy after treatment with taxanes
Patients with CIPN	Blood Collection	Patients with peripheral neuropathy after treatment with taxanes
Patients without CIPN	Patient Questionnaires	Patients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage
Patients without CIPN	Blood Collection	Patients treated with taxanes and don't develop will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age, tumor stage, chemotherapy regimen or total taxane dosage

Primary Outcome Measures

Name	Time	Method
Total score from the FACT-GOG-Ntx questionnaire	Up to 2 years	Total score from the FACT-GOG-Ntx questionnaire for peripheral neuropathy, ranging from 0-44,higher value represents a worse outcome

Secondary Outcome Measures

Name	Time	Method
Predictive value of genetic variants for the development of neuropathy	In the two weeks before start treatment	SNPs related to peripheral neuropathy
Total score from the EORTC QLQ - CIPN20 questionnaire	Up to 2 years	Total score from the EORTC QLQ - CIPN20 questionnaire for peripheral neuropathy, ranging from 20-80,higher value represents a worse outcome

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China