Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzona histopatologicznie rak piersi zaawansowany lub nieoperacyjny z cechą HER2-dodatnią
- •Pacjenci w pierwszym lub drugim rzędzie leczenia zaawansowanego nowotworu
- •Planowane leczenie zawierające pyrotinib z możliwością następnego leczenia
- •Dostęp do pełnej dokumentacji medycznej z okresu leczenia
✗ Disqualifies
- •Brak podpisanej zgody na uczestnictwo
- •Kobieta w ciąży lub karmiąca piersią
- •Jednoczesny udział w innym badaniu klinicznym
- •Inne przeciwwskazania określone przez lekarza prowadzącego
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Peking University People's Hospital
Beijing, China
Trial contact
peng yuan
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/14/2026.
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