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This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases
Enrollment
Sex
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Volunteers
Inclusion criteria
Age ≥ 18 years old, both genders
ECOG Performance Status of 0-2
Pathological tests confirm HR-negative/HER2-negative breast cancer;there is evidence of local recurrence or metastasis;not suitable with curative surgery or radiation therapy;HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is <10%;HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)
Must have life-expectancy of ≥ 3 months
MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy;
Intraventricular catheter shunting or mannitol、steroid hormone、anticonvulsant drug is allowed before enrollment, but the dose of drug should be stable for at least one week and the neurological symptoms are stable for ≥1 week
Adequate function of major organs meets the following requirements (1)Blood routine
Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Central trial contact
Biyun Wang
Data sourced from clinicaltrials.gov
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