Status:
UNKNOWN
Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the effect of pyrotinib
Detailed Description
The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive ...
Eligibility Criteria
Inclusion
- age:18-75 years old, female;
- HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
- Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Life expectancy greater than or equal to 6 months;
- The main organs function well, and the inspection indicators meet the following requirements:
- 1\) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.
Exclusion
- Patients with brain metastases by CT or MRI;
- More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
- Study drug and excipient allergy;
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Pregnant or lactating female patients;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
Key Trial Info
Start Date :
February 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05255523
Start Date
February 20 2022
End Date
December 20 2024
Last Update
February 24 2022
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