Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients
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
Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) is an antibody-conjugated drug. Results from the phase I safety, tolerability and pharmacokinetic trial of ARX788 single drug in Chinese patients with advanced HER2 breast cancer indicated a good safety of the test drug, and responses to anti-tumor therapy were observed in the target dose group. Phase II clinical trial is being carried out gradually. This trial is designed to observe the effectiveness and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients experiencing a poor efficacy of trastuzumab and pertuzumab.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku od 18 do 75 lat
- •Potwierdzony histologicznie rak piersi zaawansowany (stadium II-III)
- •Rak piersi dodatni na HER2 (potwierdzone badaniem laboratoryjnym)
- •Sprawność ogólna pacjentki 0-1 w skali ECOG
- •Prawidłowe wyniki badań krwi: białe krwinki ≥1,5, płytki ≥100, hemoglobina ≥90
- •Prawidłowa funkcja wątroby i nerek
- •Prawidłowa funkcja serca (wylot lewej komory ≥50%)
- •Dobrowolna zgoda na udział w badaniu i możliwość regularnych wizyt kontrolnych
✗ Disqualifies
- •Jednoczesne stosowanie innych leków przeciwnowotworowych
- •Rak obustronny, zapalny rak piersi lub ukryty rak piersi
- •Historia innego nowotworu w ciągu ostatnich 5 lat (z wyjątkiem raka szyjki uterusa czy czerniaka skóry)
- •Niemożność łykania, chroniczna biegunka lub niedrożność jelit
- •Choroby serca (niewydolność, zawał, arytmia, nieprawidłowy rytm serca)
- •Niekontrolowane wysokie ciśnienie krwi (powyżej 160/100 mmHg)
- •Ciężkie choroby ogólnoustrojowe lub niemożność ich kontroli
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- September 13, 2022
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Shengjing Hospital affiliated to China Medical University
Shenyang, China
Trial contact
Nan Niu, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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