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出境医 / 临床实验 / A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: SHR6390 Tablets Drug: Placebo Tablets Drug: Letrozole or Anastrozole Tablets Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: SHR6390, Letrozole or Anastrozole
SHR6390, Letrozole or Anastrozole
 Drug: SHR6390 Tablets
SHR6390 Tablets

Drug: Letrozole or Anastrozole Tablets
Letrozole or Anastrozole Tablets
Placebo Comparator: Placebo, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole
 Drug: Placebo Tablets
Placebo Tablets

Drug: Letrozole or Anastrozole Tablets
Letrozole or Anastrozole Tablets
Outcome Measures
Primary Outcome Measures :
  1. 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. ]
    Investigator-assessed Progression Free Survival


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) per RECIST 1.1 [ Time Frame: 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.

  2. OS [ Time Frame: up to 2 years ]
    Overall Survival

  3. ORR [ Time Frame: Up to approximately 24 months ]
    Objective Response Rate

  4. DoR [ Time Frame: Up to approximately 24 months ]
    Duration of Objective Response

  5. CBR [ Time Frame: Up to approximately 24 months ]
    Clinical Benefit rate

  6. 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 ]
    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


Other Outcome Measures:
  1. Ctrough [ Time Frame: Up to 4 weeks ]
    To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
China
Nayima Bayaxi
Shanghai, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE July 19, 2019
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		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. ]
Investigator-assessed Progression Free Survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • Progression-free Survival (PFS) per RECIST 1.1 [ Time Frame: 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.
  • OS [ Time Frame: up to 2 years ]
    Overall Survival
  • ORR [ Time Frame: Up to approximately 24 months ]
    Objective Response Rate
  • DoR [ Time Frame: Up to approximately 24 months ]
    Duration of Objective Response
  • CBR [ Time Frame: Up to approximately 24 months ]
    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 [ Time Frame: Up to approximately 24 months ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2019) 		Ctrough [ Time Frame: Up to 4 weeks ]
To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced Breast Cancer
Intervention  ICMJE
  • Drug: SHR6390 Tablets
    SHR6390 Tablets
  • Drug: Placebo Tablets
    Placebo Tablets
  • Drug: Letrozole or Anastrozole Tablets
    Letrozole or Anastrozole Tablets
Study Arms  ICMJE
  • Experimental: SHR6390, Letrozole or Anastrozole
    SHR6390, Letrozole or Anastrozole
    Interventions:
    • Drug: SHR6390 Tablets
    • Drug: Letrozole or Anastrozole Tablets
  • Placebo Comparator: Placebo, Letrozole or Anastrozole
    Placebo, Letrozole or Anastrozole
    Interventions:
    • Drug: Placebo Tablets
    • Drug: Letrozole or Anastrozole Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		426
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2023
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966898
Other Study ID Numbers  ICMJE SHR6390-III-302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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