Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles; Single-arm, multicenter, real-world observational studies using endocrine therapy + pyrrotinib + trastuzumab in patients with HR+, and maintenance therapy after first-line TH (P) therapy for CNS events (if non-CNS recurrent, progressive events occur and the investigator decides to change the follow-up regimen). To evaluate the effect of pyrrotinib combined with trastuzumab in maintaining treatment phase delay/reduction of brain metastases after first-line TH (P) therapy for advanced breast cancer with HER-2 positivity, the incidence of first progression of brain metastases was used as the primary endpoint.

Inclusion criteria

• Age: 18-70 years old, female;
• Pathological examination confirmed HER-2 positive invasive breast cancer; Her2-positive is defined as >10% of tumor cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results as HER2 gene amplification. A positive HER2 should be confirmed by the pathology department of the participating center of this study.) Imaging examination confirmed recurrent/metastatic breast cancer;
• Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;
• ECOG score is 0-1;
• Expected survival ≥6 months;
• Normal function of major organs;
• 1) Blood routine • ANC≥1.5×109/L; • PLT≥90×109/L; • Hb≥90 g/L; 2) Blood biochemistry • TBIL≤1.5×ULN; • ALT and AST≤2 x ULN; For patients with liver metastases, ALT and AST≤5× ULN; • BUN and Cr ≤ 1.5×ULN and creatinine removal rate ≥ 50 mL/min; 3) Heart color ultrasound • LVEF≥50%;
• The researcher believes that the subject is likely to benefit;
• Voluntarily participate in the study and sign the informed consent

Exclusion criteria

• Head MRI or head CT confirms the presence of brain metastases;
• Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);
• Study patients allergic to drugs and excipients;
• Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
• Pregnant or lactating women;
• Participated in clinical trials within 4 weeks;
• Participants considered unsuitable for inclusion by the researchers.