RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
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
This multicenter, Phase II study (RADIANT-BC01) evaluates the efficacy and safety of Disitamab Vedotin (RC48) in combination with either bevacizumab or pyrotinib in adult patients with HER2-positive metastatic breast cancer whose disease has progressed on prior trastuzumab deruxtecan (T-Dxd) therapy. Eligible participants will be randomized 1:1 to receive RC48 plus bevacizumab (7.5 mg/kg IV every 2 weeks) or RC48 plus pyrotinib (320 mg orally once daily). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or initiation of new anticancer therapy. The primary endpoint is objective response rate (ORR); key secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety. This study aims to identify new post-T-Dxd treatment options and improve outcomes for patients with advanced HER2-positive breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjentki w wieku 18 lat lub starsze.
- •Zdiagnozowany HER2-dodatni rak piersi z przerzutami.
- •Choroba postępowała pomimo leczenia T-DXd.
- •Co najmniej jedna zmiana widoczna w badaniach obrazowych.
- •Ogólny stan zdrowia pozwalający na aktywność (grupa 0 lub 1 wg skali ECOG).
- •Odpowiednie wyniki badań krwi i funkcji narządów (np. wątroby, nerek).
✗ Disqualifies
- •Pacjentki, które wcześniej otrzymywały lek RC48.
- •Aktywne infekcje wymagające leczenia.
- •Problemy z płucami w przeszłości (np. zapalenie płuc wymagające sterydów).
- •Nieuregulowane choroby serca.
- •Kobiety w ciąży lub karmiące piersią.
- •Inne aktywne nowotwory (z pewnymi wyjątkami).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 15, 2025
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Trial contact
Wei Li, Ph.D
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.