This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.
Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment
subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy
Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors
Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate/strong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate/strong CYP3A inducer within 28 days prior to first dose
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Parallel
SIM0270
DrugExperimental
Everolimus (Afinitor®)
DrugExperimental and Active comparator
Exemestane tablets
DrugActive Comparator
Fulvestrant injection
DrugActive Comparator
Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1
PFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first.
Progression free survival(PFS) , as assessed by investigator according to RECIST1.1
PFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first.
Overall Survival (OS)
OS is the time from the date of randomization to death from any cause.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Blood concentrations
Blood concentrations of SIM0270 and everolimus
Click on the lead sponsor to view all of their trials.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Nanjing Zaiming Pharmaceutical Co., Ltd.
Collaborator
