Study of Neurofilament Light Chain as a Biomarker for Predicting Paclitaxel-Induced Peripheral Neuropathy in Women With Breast Cancer

What this Trial Is About

This research aims to validate the protein neurofilament light chain NFL as a biomarker to predict the risk of developing peripheral neuropathy caused by paclitaxel treatment in patients with breast cancer. The study involves 188 patients receiving paclitaxel as neoadjuvant or adjuvant therapy. Researchers want to understand if serum NFL levels after the first treatment cycle can foresee early treatment stop due to neuropathy. Participants will continue their usual paclitaxel treatment cycles, up to a maximum of four cycles. Blood samples will be collected before treatment starts and before each new cycle to measure NFL levels. Additionally, skin biopsies will be taken before treatment and after the third or fourth cycle to assess nerve fiber health. No additional interventions will be given beyond standard care. Throughout the study, patients will undergo blood draws and skin biopsies at specified times to monitor NFL levels and nerve function. Researchers will assess how these measurements relate to paclitaxel exposure and neuropathy development. The main outcome is to see if NFL levels above 100 pgml after the first cycle predict early stopping of paclitaxel treatment due to neuropathy. The study is expected to continue until September 2027.

Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy