Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |