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

Primary Purpose

Advanced Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR6390
Placebo
Fulvestrant
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SHR6390 + Fulvestrant

Placebo + Fulvestrant

Arm Description

Intervention Drug: SHR6390, Fulvestrant

Intervention Drug: Placebo, Fulvestrant

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
AEs and SAEs
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
Ctrough

Full Information

First Posted
April 17, 2019
Last Updated
May 31, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03927456
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (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
Data Monitoring Committee
No

5. 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.

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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
357 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR6390 + Fulvestrant
Arm Type
Experimental
Arm Description
Intervention Drug: SHR6390, Fulvestrant
Arm Title
Placebo + Fulvestrant
Arm Type
Placebo Comparator
Arm Description
Intervention Drug: Placebo, Fulvestrant
Intervention Type
Drug
Intervention Name(s)
SHR6390
Intervention Description
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
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
Primary Outcome Measure Information:
Title
Investigator-assessed PFS
Description
Investigator-assessed Progression Free Survival
Time Frame
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 approximately 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
AEs and SAEs
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.
Time Frame
Up to approximately 24 months.
Title
Ctrough
Description
Ctrough
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, postmenopausal women or prepostmenopausal women Received prior endocrine therapy One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy. Eastern Cooperative Oncology Group [ECOG] 0-1 Exclusion Criteria: Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant. 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
Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35635717
Citation
Liu YP, Hu MH, Lin PP, Li T, Liu SQ, Wang YY, Li SR, Li XK, Wang CJ, Cao Y. Evaluation of the Effect of Food on the Pharmacokinetics of SHR6390, An Oral CDK4/6 Inhibitor, in Healthy Volunteers. Drugs R D. 2022 Jun;22(2):175-182. doi: 10.1007/s40268-022-00390-7. Epub 2022 May 30.
Results Reference
derived
PubMed Identifier
34737452
Citation
Xu B, Zhang Q, Zhang P, Hu X, Li W, Tong Z, Sun T, Teng Y, Wu X, Ouyang Q, Yan X, Cheng J, Liu Q, Feng J, Wang X, Yin Y, Shi Y, Pan Y, Wang Y, Xie W, Yan M, Liu Y, Yan P, Wu F, Zhu X, Zou J; DAWNA-1 Study Consortium. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med. 2021 Nov;27(11):1904-1909. doi: 10.1038/s41591-021-01562-9. Epub 2021 Nov 4.
Results Reference
derived

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

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