NCT06217185 The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
| NCT ID | NCT06217185 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2025-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-01-02 with a primary completion date of 2025-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT06217185 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06217185 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06217185 currently recruiting?
Yes, NCT06217185 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hebei Medical University Fourth Hospital to inquire about joining.
Where is the NCT06217185 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT06217185 clinical trial?
NCT06217185 is sponsored by Hebei Medical University Fourth Hospital. The trial plans to enroll 100 participants.
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