Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
A Single-arm, Multicenter, Real-world Observational Study of Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
zhangjie
60 participants
Jun 1, 2021
OBSERVATIONAL
Conditions
Summary
A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC
Eligibility
Inclusion Criteria9
- 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;
- \) 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 Criteria7
- 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.
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06754059