drugset / Trial / NCT05429684

Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

NCT05429684

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open, prospective and interventional clinical study. Patients with advanced Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer resistant to trastuzumab will be enrolled in the study. Histological specimens obtained from different metastatic foci of patients, are used to conduct genome-wide sequencing together with Circulating tumor DNA (ctDNA) of blood samples. Meanwhile, investigator will construct PDO model based on biopsy tissue. Patients as well as their paired Patient-derived organoids (PDO) models are divided into six groups according to genomic signatures. Each group of patients will receive the best targeted treatment scheme from the current clinical perspective, while the matched PDO model will accept a variety of potential effective schemes intervention. The future treatment plan of patients will be timely adjusted based on the tumor inhibition rate of PDO models. This study is the first time to explore the best individualized application sequence of targeted therapy for refractory HER2 positive breast cancer by combining genome sequencing with drug sensitivity test of PDO model. The results are expected to improve the prognosis of patients with advanced HER2 positive breast cancer.

Timeline

Start
2021-01-01
Primary completion
2024-02-28
Completion
2024-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1250 mg/m2 Oral
Subject Cindilimab (200mg, iv.drip, d1, q3w) Unknown 200 mg Intravenous
Subject Everolimus Small molecule 4 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Paclitaxel Small molecule 200 mg Intravenous
Subject Palbociclib Small molecule 125 mg Oral
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous