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

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About this study

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

Condition
HER2-positive Breast Cancer
Tested
Pyrotinib
Sponsor
zhangjie

Who can join

Age
18 to 70 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Eligible sex: Female
  • Study condition: HER2-positive Breast Cancer
  • 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 7

  • 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.

Where

1 site, 1 recruiting

Fujian Union Medical College Hospital

Fuzhou, Fujian, China

Recruiting

Potential match only. Final eligibility is determined by the study team.