Status:
RECRUITING
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
HER2-positive Breast Cancer
Advanced Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief 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 discont...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06217185
Start Date
January 2 2024
End Date
June 30 2027
Last Update
February 28 2024
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000