Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
Recruiting
Phase 2
Interventional Study
HER2-positive Advanced Breast Cancer
Brain Metastases
Radiotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 224 (estimated)
- Sponsor
- Henan Cancer Hospital · Government
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About This Trial
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 dete…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Females ≥18 yrs old;
2. Pathologically confirmed HER2-positive advanced breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. Without prior cranial radiation and had no indication for immediate …
Contacts
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