Biomarkers Investigation of Neoadjuvant Chemotherapy for Breast Cancer — BINC-B  

Breast Neoplasms Clinical Trial

Official title: The Role of Multimodal Imaging and Circulating Biomarkers in Predicting the Response of Neoadjuvant Chemotherapy for Breast Cancer

Status Recruiting

Clinical Trial Summary

The BINC-B trial is a diagnostic and interventional study in which various function imaging methods as Magnetic Resonance Imaging (PWI, DWI and DCE-MRI) and will be compared with common imaging methods (mammography and/or ultrasound) to investigate if an early response to a combined neoadjuvant chemotherapy in operable or potentially operable breast cancer. For breast cancer patients with positive HER-2, additional Herceptin could improve the response further. In this study the efficacy of combined neoadjuvant therapy with or without Herceptin should be evaluated and the role in predicting the tumor response with different imaging should be estimated.

Clinical Trial Description

Firstly, the investigators aim to show that the results of functional imaging including dynamic enhanced, diffuse weighted, and perfusion MR imaging biomarkers as well the ultrasonic outcome could be used to predict the response to the neoadjuvant chemotherapy for operable and potentially operable breast cancer (luminal B, HER-2 positive and triple negative).

Secondly, the investigators will study the role of peripheral blood biomarker including circulating tumor DNA (ctDNA), circulating endothelial cells (CECs) and subsets, myeloid-derived suppressor cells (MDSCs), and lymph cell subsets and their combinations could predict the response of the tumor measured with imaging.

Thirdly, the investigators will establish a mode with these multiple imaging and serum biomarker panel as well as their changes during the treatment course establish to predict the response to neoadjuvant chemotherapy. ;

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT03242551
• Study type: Interventional
• Source: Shenzhen People's Hospital
• Contact: Wenyong Tan, Dr
• Phone: 008618924672707
• Email: tanwyym@hotmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 8, 2017
• Completion date: December 31, 2022