Clinical trial · Interventional
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| HER2-positive Advanced Breast Cancer | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FSRT or WBRT | Radiation | — | UNRESOLVED |
| Trastuzumab Rezetecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Trastuzumab Rezetecan
- interventionNames
- Drug: Trastuzumab Rezetecan
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Trastuzumab Rezetecan combined with radiotherapy
- interventionNames
- Drug: Trastuzumab Rezetecan
- Radiation: FSRT or WBRT
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 1.5 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 local treatment or refuse to local treatment; 5. Life expectancy is not less than 6 months. 6. Adequate function of major organs. Exclusion Criteria: 1. Subjects with leptomeningeal metastasis 2. CNS complications requiring emergency neurosurgical intervention 3. 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; 4. Suffering from heart disease that is not well controlled or having clinical symptoms 5. History of clinically significant lung disease； 6. 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. 7. Female subjects during pregnancy and lactation 8. Any other conditions that researchers believe that patients are unsuitable for this study.
References
Publications (0)
Data not yet available