Recruiting

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

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).

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ClinicalTrials.gov IDNCT06217185
PhasePHASE4
Enrollment100
SponsorHebei Medical University Fourth Hospital
Age18 Years and older
SexFEMALE
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Conditions studied

HER2-positive Breast Cancer, Advanced Breast Cancer

About this study

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).

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: 1. Age: 18-70 years old, female; 2. 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) 3. Imaging confirmed recurrent/metastatic breast cancer; 4. Patients who relapsed and metastasized three months after discontinuation of Trastuzumab treatment; 5. Have at least one measurable lesion (according to RECIST 1.1 criteria); 6. ECOG score of 0-2; 7. Expected life span ≥3 months; 8. Normal major organ function; 9. The researcher believes that the participant may benefit; 10. Volunteer to participate in this study, sign informed consent. Exclusion Criteria: Patients who meet any of the following criteria are not eligible for participation: 1. Have any confirmed history of drug allergies, or severe allergic reactions to any component of the investigational drug (NCI-CTCAE 5.0 grade \> 3); 2. Patients in advanced stages who have undergone systemic treatment; 3. A history of serious heart diseases such as congestive heart failure, unstable angina, arrhythmia or myocardial infarction; 4. Suffer from serious pulmonary diseases, such as interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, etc.; 5. 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; 6. 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); 7. Other invasive tumors (including second primary breast cancer) that may affect the evaluation of results and adherence to the protocol; 8. Having undergone major surgical procedure or are yet to recover from major internal diseases within the 4 weeks prior to the study; 9. Any circumstance that the researcher considers the participant unfit to participate in the study.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.