breast cancer
Conditions
Interventions
trial group:pyrotinib combined with capecitabine
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-70 years 2. HER2 overexpression was histologically confirmed in primary and/or metastatic foci of breast cancer: immunohistochemical 3+ or 2+ and verified HER2 amplification was detected by fluorescence in situ hybridization (FISH) 3. Enhanced MRI revealed at least one measurable metastasis to the brain with a diameter =10 mm 4. ECOG 0 ~2 5. Blood routine, liver function, kidney function assessment can tolerate treatment 6. LVEF >= 50% in ehocardiography 7. In line with the indications in the drug instructions Pyrotinib combined with capecitabine is suitable for the treatment of recurrent or metastatic breast cancer patients who are positive for epidermal growth factor receptor 2 (HER2) and have not received or received trastuzumab before. Patients should receive chemotherapy with anthracyclines or taxanes before using pyrotinib. 8. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Isolated brain metastases are suitable for surgical resection after evaluation; 2. level II cardiac function, respiratory failure and blood system diseases; 7. Patients with mental and neurological diseases; 8. May be allergic to pyrotinib and its components; 9. Pregnancy; 10. Participants in other clinical trials in the same period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR every 6 weeks; | — |
Countries
China
Contacts
Public ContactZhaohui Chu
Department of Oncology, Huashan Hospital, Fudan University
Outcome results
None listed