A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Primary Purpose
Advanced Breast Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR6390 Tablets
Placebo Tablets
Letrozole or Anastrozole Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
- Age: 18 - 75 years old
- No prior systemic anti-cancer therapy for advanced HR+ disease.
- Eastern Cooperative Oncology Group [ECOG] 0-1
Exclusion Criteria:
- Patients who received prior treatment with any CDK4/6 inhibitor.
- 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.
Sites / Locations
- Nayima Bayaxi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SHR6390, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole
Arm Description
SHR6390, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole
Outcomes
Primary Outcome Measures
Investigator-assessed PFS
Investigator-assessed Progression Free Survival
Secondary Outcome Measures
Progression-free Survival (PFS) per RECIST 1.1
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.
OS
Overall Survival
ORR
Objective Response Rate
DoR
Duration of Objective Response
CBR
Clinical Benefit rate
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
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
Full Information
NCT ID
NCT03966898
First Posted
May 21, 2019
Last Updated
May 31, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03966898
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
426 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR6390, Letrozole or Anastrozole
Arm Type
Experimental
Arm Description
SHR6390, Letrozole or Anastrozole
Arm Title
Placebo, Letrozole or Anastrozole
Arm Type
Placebo Comparator
Arm Description
Placebo, Letrozole or Anastrozole
Intervention Type
Drug
Intervention Name(s)
SHR6390 Tablets
Intervention Description
SHR6390 Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo Tablets
Intervention Description
Placebo Tablets
Intervention Type
Drug
Intervention Name(s)
Letrozole or Anastrozole Tablets
Intervention Description
Letrozole or Anastrozole Tablets
Primary Outcome Measure Information:
Title
Investigator-assessed PFS
Description
Investigator-assessed Progression Free Survival
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.
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) per RECIST 1.1
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.
Time Frame
Up to approximately 24 months
Title
OS
Description
Overall Survival
Time Frame
up to 2 years
Title
ORR
Description
Objective Response Rate
Time Frame
Up to approximately 24 months
Title
DoR
Description
Duration of Objective Response
Time Frame
Up to approximately 24 months
Title
CBR
Description
Clinical Benefit rate
Time Frame
Up to approximately 24 months
Title
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
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
Time Frame
Up to approximately 24 months
Other Pre-specified Outcome Measures:
Title
Ctrough
Description
To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors
Time Frame
Up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
Age: 18 - 75 years old
No prior systemic anti-cancer therapy for advanced HR+ disease.
Eastern Cooperative Oncology Group [ECOG] 0-1
Exclusion Criteria:
Patients who received prior treatment with any CDK4/6 inhibitor.
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.
Facility Information:
Facility Name
Nayima Bayaxi
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
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