Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer

What this Trial Is About

Researchers are conducting a prospective observational study to evaluate circulating tumor DNA (ctDNA) levels in female patients diagnosed with stage II-III HER2-positive or triple negative breast cancer who are scheduled for neoadjuvant chemotherapy. The study aims to determine ctDNA detection rates before, during, and after treatment, and to explore how ctDNA levels and MRI imaging relate to pathological complete response (pCR) following therapy. Participants will undergo neoadjuvant chemotherapy regimens such as AC-T, AC-TH, TCH, or TCHP, with allowance for changes if clinically necessary. Blood samples for ctDNA analysis will be collected at diagnosis, during treatment, and after therapy, alongside tumor tissue samples. Imaging studies including ultrasound, MRI, CT scans, chest x-rays, and PET-CT will be performed throughout to monitor response and compare with ctDNA findings. During the approximately one-year study period, participants will provide demographic and medical history information and attend routine clinical visits where imaging and laboratory tests will be performed. Researchers will assess ctDNA changes and correlate these with MRI results and pCR outcomes to evaluate the prognostic value of combining ctDNA detection and imaging. Safety monitoring and data collection will continue throughout the follow-up.

Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment