Fudan University Breast Cancer Neoadjuvant Therapy Precision Study Using Novel and Standard Treatments

What this Trial Is About

This research aims to explore precision neoadjuvant therapy in operable breast cancer patients who meet indications for neoadjuvant chemotherapy. It focuses on clinical subtypes to better tailor treatments by using updated translational research, including refined tumor typing, new target discoveries, and novel drug development. The study is a phase 2 platform trial designed to compare new drug therapies alone or combined with standard chemotherapy against standard therapy alone, based on molecular subtypes of breast cancer. Participants are assigned randomly to either a precision treatment group or a conventional neoadjuvant chemotherapy group according to their molecular subtype. Treatments include various novel targeted drugs and combinations, such as CDK46 inhibitors, anti-HER2 antibody-drug conjugates, anti-PD1 or PD-L1 antibodies, tyrosine kinase inhibitors, and stereotactic body radiation therapy SBRT prior to drug therapy in some subtypes. The study adapts over time, adding or dropping treatment arms based on ongoing research findings and biomarker signatures. During the study, participants will undergo assessments including pathological complete response rate pCR evaluation up to 24 weeks, gene expression profiling, peripheral blood mononuclear cell counts, and safety monitoring using CTCAE criteria for about one year. Additional outcomes include invasive disease-free survival tracked for three years post-surgery and overall response rate within 24 weeks. Participants will be monitored regularly with clinical and laboratory tests to evaluate treatment effects and safety throughout the trial.

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy