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

Breast Cancer Clinical Trial

Official title: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)

Status Recruiting

Clinical Trial Summary

The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.

Clinical Trial Description

FASCINATE-N is a platform that will compare the efficacy of novel drugs alone or in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is to identify improved treatment regimens for subsets on the basis of clinical subtyping. In this trial, breast cancer patients eligible for inclusion can be randomly divided into the precision treatment group and conventional neoadjuvant chemotherapy group according to molecular typing and subtyping. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs. As described for previous adaptive trials, regimens that show to be more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm
• Breast Neoplasms
• Breast Tumors
• Early-stage Breast Cancer
• HER2-negative Breast Cancer
• HER2-positive Breast Cancer
• Hormone Receptor Positive Tumor
• Locally Advanced Breast Cancer
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer (TNBC)

• NCT number: NCT05582499
• Study type: Interventional
• Source: Fudan University
• Contact: Zhimin Shao, Professor
• Phone: +86(021)64175590
• Email: zhimingshao@yahoo.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2022
• Completion date: September 2025