Actively Recruiting
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan Alone in HER2-positive Advanced Breast Cancer With Brain Metastases: An Open-label, Randomized Controlled Trial
Led by Henan Cancer Hospital · Updated on 2025-08-11
224
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HER2-positive advanced breast cancer with brain metastases to compare two treatment approaches. The trial aims to evaluate the effects of Trastuzumab Rezetecan combined with radiotherapy versus Trastuzumab Rezetecan alone. This randomized, open-label Phase 2 trial plans to enroll 224 female participants aged 18 years and older who have measurable brain lesions and a life expectancy of at least six months. Participants will be randomly assigned to receive either Trastuzumab Rezetecan alone at a dose of 4.8 mg/kg every three weeks or Trastuzumab Rezetecan combined with focused stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT). Treatment continues until disease progression, intolerable side effects, withdrawal, or study termination. Radiotherapy is delivered as FSRT with 8 Gy over 3 to 5 fractions or WBRT with 30 Gy over 10 fractions. Throughout the study, participants will undergo assessments including progression-free survival measured up to 1.5 years, central nervous system objective response rate, overall response rate by investigators, and monitoring of adverse events. These evaluations will occur at intervals such as 2 months and up to 1.5 years. The study includes ongoing safety monitoring and aims to gather detailed information on treatment effects in this patient group.
CONDITIONS
Brief Title
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Pathologically confirmed HER2-positive advanced breast cancer
- At least one measurable brain lesion not previously treated locally
- No prior cranial radiation and no immediate need for local brain treatment or refusal of such treatment
- Life expectancy of at least 6 months
- Adequate function of major organs
You will not qualify if you...
- Presence of leptomeningeal metastasis
- Central nervous system complications requiring emergency neurosurgery
- Previous treatment with trastuzumab deruxtecan or similar antibody-drug conjugates
- Uncontrolled heart disease or clinical symptoms related to heart disease
- History of significant lung disease
- Diagnosis of other malignant tumors in the past 5 years, except certain cured skin and cervical cancers
- Pregnancy or breastfeeding
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1.5 years
Participants receive treatment with Trastuzumab Rezetecan, either alone or combined with radiotherapy, to manage HER2-positive advanced breast cancer with brain metastases.
Infusions every 3 weeks; radiotherapy schedules vary between 3 to 10 sessions depending on type
Trial Site Locations
Total: 1 location
1
Professor
Zhengzhou, Henan, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here