Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
Recruiting · NCT07100600 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
FSRT or WBRTTrastuzumab Rezetecan
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).
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Professor - Zhengzhou, Henan, China