Pyrotinib-based regimens for advanced HER2-positive breast cancer: real-world sequential therapy after progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective real-world study will enroll up to 500 adults with HER2-positive inoperable locally advanced or metastatic breast cancer who are receiving first- or second-line therapy. It examines sequential use of disitamab vedotin following disease progression or intolerance to pyrotinib-based regimens, with pyrotinib plus trastuzumab and chemotherapy as first-line and pyrotinib plus capecitabine as second-line. Primary endpoint is real-world second progression-free survival (rwPFS2); secondary endpoints include rwPFS, tumor response, overall survival, time to treatment failure, safety, and patient-reported outcomes. The study seeks to reflect real clinical practice across a single center, focusing on safety and effectiveness of sequential therapy in routine care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years old;
2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
3. Patients with first-line or second-line advanced disease:

   First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant/adjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant/adjuvant chemotherapy and HER2-targeted therapy;
4. Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;
5. Traceable medical records available throughout the treatment period.

Exclusion Criteria:

1. Failure to sign the informed consent form;
2. Pregnant or lactating females;
3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;
4. Other conditions deemed ineligible for enrollment by the investigator's judgment.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: peng yuan
• Email: 13671287670@163.com
• Phone: 86+13671287670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.