Actively Recruiting
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-07-15
74
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- HER2-positive advanced or metastatic breast cancer confirmed by specific tests
- Previous treatment with trastuzumab deruxtecan (T-DXd) with documented disease progression
- At least one measurable tumor lesion at baseline
- ECOG performance status of 0 or 1
- Adequate organ and marrow function, including specific blood counts and liver and kidney function
- Estimated life expectancy of at least 12 weeks
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Previous treatment with disitamab vedotin (RC48)
- Active infections requiring systemic treatment
- History of interstitial lung disease or pneumonitis needing corticosteroids
- Uncontrolled heart diseases such as recent heart attack, unstable angina, or heart failure
- Pregnant or breastfeeding women
- Other cancers unless treated and disease-free for 5 years
- Participation in another ongoing investigational clinical trial
- Any condition that may interfere with study compliance or safety as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
W
Wei Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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