Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effect of pyrotinib
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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 advanced breast cancer
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm 1 Pyrotinib:400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle. |
Drug: pyrotinib
After 4-6 cycles of taxane chemotherapeutics combined with trastuzumab±pertuzumab, the assessment result reaches CR or PR, and the subsequent sequential pyrrotinib plus capecitabine±trastuzumab to CNS Progress
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of first progression with brain metastases [24 month]
Incidence of first progression with brain metastases
Secondary Outcome Measures
- ORR without CNS [24 month]
Baseline to measured stable disease without central nervous system
- TTBM [24 month]
Time to brain metastases
Eligibility Criteria
Criteria
Inclusion Criteria:
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age:18-75 years old, female;
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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;
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Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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Life expectancy greater than or equal to 6 months;
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The main organs function well, and the inspection indicators meet the following requirements:
- 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 Criteria:
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Patients with brain metastases by CT or MRI;
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More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
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Study drug and excipient allergy;
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History of psychiatric drugs abuse and can't quit or patients with mental disorders;
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Pregnant or lactating female patients;
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Less than 4 weeks from the last clinical trial;
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The researchers think inappropriate.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Medical University Union Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 001