The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Early Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Hebei Medical University Fourth Hospital
100 participants
Jan 2, 2024
INTERVENTIONAL
Conditions
Summary
This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Eligibility
Inclusion Criteria11
- 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.
Exclusion Criteria10
- Patients who meet any of the following criteria are not eligible for participation:
- Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade \> 3);
- Patients in advanced stages who have undergone systemic treatment;
- 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.;
- 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;
- 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;
- Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study;
- Any circumstance that the researcher considers the participant unfit to participate in the study.
Interventions
Pyrotinib 400mg qd po continuously
For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks
Taxanes: Usual clinical dose is administered, in a 21-day cycle.
Capecitabine: 650mg/m2 each time, given twice daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06217185