This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Radiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced. Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg
Fudan University Shanghai Cancer Center
Shanghai, China
Intracranial objective response rate(IC-ORR)
Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors as defined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria.
Time frame: 2 years
Intracranial CNS Progression Free Survival(IC-PFS)
Time from treatment until the first date of intracranial disease progression or death due any cause. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment.
Time frame: 2 years
Progression Free Survival(PFS)
Time from treatment until the first date of intracranial or extracranial disease progression or death due any cause. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment.
Time frame: 2 years
Overall survival(OS)
Time from the treatment until to the date of death, regardless of the cause of death
Time frame: 3 years
Percentage of Participants With Adverse Events Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0
Time frame: 2 years
Health-related quality of life per FACT-BR
Health-related quality of life was evaluated using the QLQ-C30 questionnaires to assess Health-related quality of life was evaluated using the FACT-BR questionnaires to assess the quality of life
Time frame: 2 years
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Local control rate
The percentage of participants who have achieved complete response, partial response and stable disease according to RANO-BM criteria after treatment
Time frame: 2 years
Neurocognitive function per HVLT-R
Neurocognitive function was evaluated using HVLT-R test
Time frame: 2 years