Status:
UNKNOWN
Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
HER2+ Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
In previous studies, investigator found that dynamic genomics detection of metastatic foci can fully reveal the mechanism of trastuzumab resistance. Different anti-HER2 treatment strategies for differ...
Eligibility Criteria
Inclusion
- 18-70 years old;
- Women;
- ECOG score 0-2;
- Locally advanced or metastatic breast cancer confirmed by histopathology;
- Positive HER2 expression in cancer tissues (IHC 3 +, or IHC 2 + but FISH amplification);
- Resistant to trastuzumab (including disease progression during or after withdrawal of trastuzumab);
- There were enough specimens for immunohistochemistry, gene detection and establishment of PDO model;
- Hematology and liver and kidney function were normal within 2 weeks before treatment;
- Imaging examination showed measurable lesions (according to RECIST v1.1);
- Women of childbearing age agree to contraception or take contraceptive measures;
- Be able to understand the research program and participate voluntarily.
Exclusion
- Symptomatic, untreated or progressive central nervous system metastases;
- Severe heart disease (poor cardiac function);
- Within 5 years, there was a history of other malignant tumors other than breast cancer;
- In this study, chemotherapy, radiotherapy, immunotherapy or surgery were performed within 3 weeks before the first treatment;
- Patients who are pregnant or lactating, or plan to become pregnant during enrollment.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05429684
Start Date
January 1 2021
End Date
February 28 2024
Last Update
June 23 2022
Active Locations (2)
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1
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
2
Jin Yang
Xi'an, Shaanxi, China, 710061