Advanced Breast Cancer
Conditions
Brief summary
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
Interventions
DRUGSHR6390
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
DRUGPlacebo
Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
DRUGFulvestrant
Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer. 2. Age: 18 - 75 years old, postmenopausal women or prepostmenopausal women 3. Received prior endocrine therapy 4. One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy. 5. Eastern Cooperative Oncology Group \[ECOG\] 0-1
Exclusion criteria
1. Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant. 2. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed PFS | Up to approximately 24 months. | Investigator-assessed Progression Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Up to approximately 2 years | Overall Survival |
| ORR | Up to approximately 24 months. | Objective Response Rate |
| DoR | Up to approximately 24 months | Duration of Objective Response |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to approximately 24 months. | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first. |
| AEs and SAEs | Up to approximately 24 months. | Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03. |
| Ctrough | Up to 4 weeks | Ctrough |
| CBR | Up to approximately 24 months. | Clinical Benefit rate |
Countries
China
Outcome results
None listed