Status:
UNKNOWN
Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
Brief Summary
This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive ...
Detailed Description
This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to ass...
Eligibility Criteria
Inclusion
- Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization \[FISH\] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
- Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
- Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
- For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
- There are traceable medical history data.
Exclusion
- Patients enrolled in the previous PERMEATE study;
- The research program is receiving other anti-tumor drug treatment at the same time;
- The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
- Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
- The investigator believes that the patient is not suitable to enter this study.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05359120
Start Date
May 30 2022
End Date
May 1 2024
Last Update
September 19 2022
Active Locations (1)
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1
Henan cancer hospital
Zhengzhou, Henan, China, 450008