Description:
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in
combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or
Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast
cancer and have not received systemic anticancer therapy are eligible for this study.
Title
- Brief Title: A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
- Official Title: A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
SHR6390-III-302
- NCT ID:
NCT03966898
Conditions
Interventions
Drug | Synonyms | Arms |
---|
SHR6390 Tablets | | SHR6390, Letrozole or Anastrozole |
Placebo Tablets | | Placebo, Letrozole or Anastrozole |
Letrozole or Anastrozole Tablets | | Placebo, Letrozole or Anastrozole |
Purpose
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in
combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or
Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast
cancer and have not received systemic anticancer therapy are eligible for this study.
Trial Arms
Name | Type | Description | Interventions |
---|
SHR6390, Letrozole or Anastrozole | Experimental | SHR6390, Letrozole or Anastrozole | - SHR6390 Tablets
- Letrozole or Anastrozole Tablets
|
Placebo, Letrozole or Anastrozole | Placebo Comparator | Placebo, Letrozole or Anastrozole | - Placebo Tablets
- Letrozole or Anastrozole Tablets
|
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
3. No prior systemic anti-cancer therapy for advanced HR+ disease.
4. Eastern Cooperative Oncology Group [ECOG] 0-1
Exclusion Criteria:
1. Patients who received prior treatment with any CDK4/6 inhibitor.
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: | Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, 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 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: | 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 v5.0 |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | Number of Participants With adverse events and serious adverse events Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0 |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
Last Updated
June 2, 2021