Actively Recruiting
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
Led by Henan Cancer Hospital · Updated on 2025-08-11
224
Participants Needed
1
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).
CONDITIONS
Official 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 intracranial lesion not previously treated locally
- No prior cranial radiation and no need for immediate local treatment or refusal of local treatment
- Life expectancy of at least 6 months
- Adequate function of major organs
You will not qualify if you...
- Presence of leptomeningeal metastasis
- CNS complications requiring emergency neurosurgery
- Previous treatment with trastuzumab deruxtecan or similar antibody drug conjugates with exatecan derivative
- Uncontrolled heart disease or clinical symptoms
- History of significant lung disease
- Other cancers diagnosed in the past five years except cured cervical carcinoma in situ or certain skin cancers
- Pregnancy or breastfeeding
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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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
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