Description:
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.
Title
- Brief Title: A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
- Official Title: A Phase III Study to Evaluate the Efficacy and Safety of SHR6390 in Combination With Fulvestrant Versus Placebo Combined With Fulvesrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
SHR6390-III-301
- NCT ID:
NCT03927456
Conditions
Interventions
Drug | Synonyms | Arms |
---|
SHR6390 | | SHR6390 + Fulvestrant |
Placebo | | Placebo + Fulvestrant |
Fulvestrant | | Placebo + Fulvestrant |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
SHR6390 + Fulvestrant | Experimental | Intervention Drug: SHR6390, Fulvestrant | |
Placebo + Fulvestrant | Placebo Comparator | Intervention Drug: Placebo, Fulvestrant | |
Eligibility Criteria
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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Investigator-assessed PFS |
Time Frame: | Up to approximately 24 months. |
Safety Issue: | |
Description: | Investigator-assessed Progression Free Survival |
Secondary Outcome Measures
Measure: | Progression-free Survival (PFS) per RECIST 1.1 |
Time Frame: | Up to approximately 24 months. |
Safety Issue: | |
Description: | 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. |
Measure: | OS |
Time Frame: | Up to approximately 2 years |
Safety Issue: | |
Description: | Overall Survival |
Measure: | ORR |
Time Frame: | Up to approximately 24 months. |
Safety Issue: | |
Description: | Objective Response Rate |
Measure: | DoR |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | Duration of Objective Response |
Measure: | CBR |
Time Frame: | Up to approximately 24 months. |
Safety Issue: | |
Description: | Clinical Benefit rate |
Measure: | AEs and SAEs |
Time Frame: | Up to approximately 24 months. |
Safety Issue: | |
Description: | 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. |
Measure: | Ctrough |
Time Frame: | Up to 4 weeks |
Safety Issue: | |
Description: | Ctrough |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
Last Updated
June 3, 2021