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.
Age ≥18 years.
Histologically or cytologically confirmed HER2-positive (IHC 3+ or IHC 2+ with ISH amplification) advanced or metastatic breast cancer.
Prior treatment with trastuzumab deruxtecan (T-DXd) and documented disease progression during or after therapy.
At least one measurable lesion at baseline as defined by RECIST v1.1.
Prior treatment with disitamab vedotin (RC48).
Active infections requiring systemic therapy (bacterial, viral, or fungal).
History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid therapy.
Uncontrolled cardiovascular disease, including but not limited to: uncontrolled hypertension, recent myocardial infarction (within 6 months), unstable angina, or congestive heart failure.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
RenJi Hospital
Collaborator
Anhui Provincial Hospital
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
The First Hospital of Jilin University
Collaborator
Shanghai Minhang Central Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Huai'an First People's Hospital
Collaborator