Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trastuzumab Rezetecan, FSRT or WBRT.
- Who it may be relevant to
- Registry conditions: HER2-positive Advanced Breast Cancer, Brain Metastases, Radiotherapy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
Overview
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).
Interventions
- Drug Trastuzumab Rezetecan
Trastuzumab Rezetecan：4.8mg/kg Q3W - Radiation FSRT or WBRT
FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）
Primary outcome measures
- PFS [Time frame: up to 1.5 years]
Secondary outcome measures (4)
- CNS-ORR [Time frame: 2 months]
- ORR by investigator using RECIST Guideline [Time frame: 2 months]
- CNS-PFS [Time frame: 1.5 year]
- Adverse events [Time frame: up to 1.5 years]
Eligibility criteria
Inclusion criteria
- Females ≥18 yrs old;
- Pathologically confirmed HER2-positive advanced breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
- Life expectancy is not less than 6 months.
- Adequate function of major organs.
Exclusion criteria
- Subjects with leptomeningeal metastasis
- CNS complications requiring emergency neurosurgical intervention
- Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
- Suffering from heart disease that is not well controlled or having clinical symptoms
- History of clinically significant lung disease；
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- Female subjects during pregnancy and lactation
- Any other conditions that researchers believe that patients are unsuitable for this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Professor — Zhengzhou
Identifiers
NCT: NCT07100600 · 2025-408-001