The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Korábbi kezelés

• Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade > 3);
• Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study;

Más betegség

• A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction;
• Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.;
• Comorbidity or condition that may interfere with their participation in the study, or any serious medical impediment that might affect participant's safety (such as, active or uncontrolled infection, active liver/gallbladder disease requiring antiviral treatment);
• Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol;

Laborértékek

• Currently suffering from severe liver-related diseases, such as acute hepatitis, explosive hepatitis, coagulation factor synthesis disorder, etc.; Those who are positive for HBV surface antigen or HBV core antibody must have a peripheral blood Hepatitis B virus DNA titer test < 1×10 \^3 IU/ml in order to participate;

Egyéb

• Patients who meet any of the following criteria are not eligible for participation:
• Patients in advanced stages who have undergone systemic treatment;
• Any circumstance that the researcher considers the participant unfit to participate in the study.

• Age: 18-70 years old, female;
• Pathological examination confirmed HER-2 positive invasive breast cancer; (HER2 positivity is defined as an immunohistochemical (IHC) score of 3+ or in-situ hybridization (ISH) result for HER2 gene amplification in >10% of immunoreactive cells.
  • HER2 positivity needs to be verified by the pathology department of the research center involved in this study)
• Imaging confirmed recurrent/metastatic breast cancer;
• Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment;
• Have at least one measurable lesion (according to RECIST 1.1 criteria);
• ECOG score of 0-2;
• Expected life span ≥3 months;
• Normal major organ function;
• The researcher believes that the participant may benefit;
• Volunteer to participate in this study, sign informed consent.