免费获得国外相关药品，最快 1 个工作日回馈药物信息

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

A Study of SHR6390 in Combination With Fulvestrant 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 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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: SHR6390 Drug: Placebo Drug: Fulvestrant Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: SHR6390 + Fulvestrant
Intervention Drug: SHR6390, Fulvestrant
 Drug: SHR6390
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Drug: Fulvestrant
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
Placebo Comparator: Placebo + Fulvestrant
Intervention Drug: Placebo, Fulvestrant
 Drug: Placebo
Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Drug: Fulvestrant
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
Outcome Measures
Primary Outcome Measures :
  1. Investigator-assessed PFS [ Time Frame: 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 approximately 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. AEs and SAEs [ Time Frame: 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.

  7. Ctrough [ Time Frame: Up to 4 weeks ]
    Ctrough


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, 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.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Chinese Academy of Medical Science
Beijing, Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Investigator-assessed PFS [ Time Frame: 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: April 24, 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 approximately 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
  • AEs and SAEs [ Time Frame: 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 [ Time Frame: Up to 4 weeks ]
    Ctrough
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Advanced Breast Cancer
Intervention  ICMJE
  • Drug: SHR6390
    SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
  • Drug: Placebo
    Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
  • Drug: Fulvestrant
    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
Study Arms  ICMJE
  • Experimental: SHR6390 + Fulvestrant
    Intervention Drug: SHR6390, Fulvestrant
    Interventions:
    • Drug: SHR6390
    • Drug: Fulvestrant
  • Placebo Comparator: Placebo + Fulvestrant
    Intervention Drug: Placebo, Fulvestrant
    Interventions:
    • Drug: Placebo
    • Drug: Fulvestrant
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 31, 2021) 		357
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		288
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2021   (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, 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.
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 NCT03927456
Other Study ID Numbers  ICMJE SHR6390-III-301
Has Data Monitoring Committee No
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

治疗医院

新药特效药

治疗案例

前沿医讯