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.

Conditions

• HER2+ Breast Cancer

Interventions

DRUG

Trastuzumab

Trastuzumab (6mg/Kg, iv.drip, d1, q3w)

DRUG

Pertuzumab

Patuzumab (420mg iv.drip, d1,q3w)

DRUG

Nab paclitaxel

nab-paclitaxel (200mg iv.drip, d1,d8, q3w)

DRUG

Pyrotinib

Pyroltinib (400mg po qd)

DRUG

Capecitabine

Capecitabine (1250mg/m2, po, bid, d1-d14, q3w).

DRUG

T-DM1

T-DM1(3.6mg/Kg, iv.drip, d1, q3w)

DRUG

Everolimus

Everolimus (4mg, po, qd)

DRUG

CDK4/6 inhibitor

Palbociclib (125mg, po, qd)

DRUG

AI

Letrozole (2.5mg, qd).

DRUG

Anti-PD-1 monoclonal antibody

Cindilimab (200mg, iv.drip, d1, q3w)

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Jin Yang, Doctor · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2024-02-28

Completion

2024-02-28

Countries

• China

Study Locations