This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
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.
History of other malignancies prior to the start of study treatment.
Patients with known metastases to central nervous system.
Parallel
SPH4336 Tablets
DrugSPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
SPH4336 Tablets Placebo
DrugSPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
Objective response rate
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Progression-free survival (PFS)
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Cmax
PK (Pharmacokinetics) parameters
Tmax
PK (Pharmacokinetics) parameters
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause
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