Treatment for HER2-positive advanced breast cancer using Pyrotinib, Trastuzumab, and Taxanes

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

This study is testing a new combination treatment of Pyrotinib, Trastuzumab, and Taxanes to see if it helps people with HER2-positive advanced breast cancer who have already been treated with Trastuzumab.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: Trastuzumab, Pyrotinib, chemotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06217185 on ClinicalTrials.gov

What this trial studies

This multi-center real-world study aims to evaluate the efficacy and safety of a combination treatment involving Pyrotinib, Trastuzumab, and Taxanes in patients with HER2-positive advanced breast cancer who have previously received Trastuzumab. Participants will undergo 6-8 cycles of Taxanes, after which they may switch to Capecitabine combined with Pyrotinib and Trastuzumab. The study will assess treatment outcomes and adverse events to determine the overall effectiveness of this regimen.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with confirmed HER2-positive invasive breast cancer and measurable lesions who have relapsed after previous Trastuzumab treatment.

Not a fit: Patients with confirmed high-risk conditions or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced HER2-positive breast cancer who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and chemotherapy in treating HER2-positive breast cancer.

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.

Where this trial is running

Shijiazhuang, Hebei

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)

Conditions HER2-positive Breast Cancer; Advanced Breast Cancer