This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.
Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
Life expectancy ≥ 3 months.
Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.
Inflammatory breast cancer.
Patients unsuitable for endocrine therapy at the investigator's discretion.
Have a History of other malignancies prior to the start of study treatment.
Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
Single group
SPH4336 Tablets
DrugSPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion; Exemestane：Administered by oral.
Intracranial Objective response rate（iORR）
Objective response rate according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria.
Intracranial Duration of remission (iDOR)
DoR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause.
Intracranial Disease control rate (iDCR)
Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported.
Progression-free survival (PFS)
measured by RANO-BM and RECIST 1.1
Overall Survival (OS)
Determination of the overall survival times of all patients.
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