NCT07600164RecruitingPhase 4
Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration. This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment. It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine). The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes. It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 7 May 2026
- Start date
- 6 Jul 2026
- Primary completion date
- 30 Dec 2031
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07600164
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 500
- From 6 Jul 2026 to the primary completion date, 30 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;
Other illness
- Failure to sign the informed consent form;
- Other conditions deemed ineligible for enrollment by the investigator's judgment.
Other
- Pregnant or lactating females;
Who the study is looking for
- Aged ≥ 18 years old;
- Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;
- 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;
- 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;
- Traceable medical records available throughout the treatment period.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.