Locally Advanced or Metastatic Breast Cancer
Conditions
Brief summary
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.
Interventions
Sponsors
Nanjing Zaiming Pharmaceutical Co., Ltd.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer 2. Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion 3. 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 4. Have disease that has demonstrated progression on or after prior treatment: 1. 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 2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting. 5. Eastern Cooperative Oncology Group Performance Status 0-1 6. Adequate organ function
Exclusion criteria
1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors 2. 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 3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term 4. Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease 5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol 6. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1 | 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) , as assessed by investigator according to RECIST1.1 | 2 year | 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) | 3 year | 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) | 3 year | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 |
| Blood concentrations | At five specified time points of the first 6 cycles (each cycle is 28 days) | Blood concentrations of SIM0270 and everolimus |
| Objective Response Rate (ORR) by investigator | 2 year | The objective response rate is defined as the percentage of subjects with a complete response or partial response. |
| ORR by BIRC | 2 year | The objective response rate is defined as the percentage of subjects with a complete response or partial response. |
| Objective Response Rate (DOR) by investigator | 2 year | The DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause. |
| Clinical benefit rate(CBR) by investigator | 2 year | The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks. |
| CBR by BIRC | 2 year | The clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks. |
| Time To Progression (TTP) by investigator | 2 year | TTP is defined as the time from randomization until the date of first documented progression. |
| Time To Progression (TTP) by BIRC | 2 year | TTP is defined as the time from randomization until the date of first documented progression. |
| Change from baseline in EQ-5D-5L scores | 2 year | Change from baseline in EQ-5D-5L scores |
| Change from baseline in FACT-B scores | 2 year | Change from baseline in FACT-B scores |
| DOR by BIRC | 2 year | The DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause. |
Countries
China
Contacts
Primary ContactJING WANG
Outcome results
None listed