Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
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
The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are: * Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP. * Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment. Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab. Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18-75 lat z potwierdzonym rakiem piersi z przerzutami
- •Nowotwór z dodatnim receptorem HER2 (potwierdzony badaniem patologicznym)
- •Brak poprzedniej chemioterapii na przerzuty
- •Co najmniej jeden widoczny guz, który można zmierzyć
- •Ogólny stan zdrowia pozwalający na udział w badaniu i spodziewana przeżywalność co najmniej 3 miesiące
- •Działania niepożądane z poprzednich leczenia musiały ustąpić do minimalnego poziomu
- •Prawidłowe wyniki badań krwi (białe ciałka, neutrofile, płytki krwi)
- •Prawidłowe wyniki badań wątroby, nerek i serca, w tym prawidłowa funkcja serca
✗ Disqualifies
- •Nowotwór z ujemnym receptorem HER2
- •Alergia na składniki leku badawczego
- •Ciąża, karmienie piersią lub dodatni test ciążowy
- •Choroby uniemożliwiające udział w badaniu, takie jak niekontrolowana choroba serca, wysokie ciśnienie, aktywne zakażenia lub nieaktywna hepatitis B
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- February 26, 2024
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, China
Trial contact
Herui Yao, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.