Clinical Trials /

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

NCT03927456

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: SHR6390-III-301
  • NCT ID: NCT03927456

Conditions

  • Advanced Breast Cancer

Interventions

DrugSynonymsArms
SHR6390SHR6390 + Fulvestrant
PlaceboPlacebo + Fulvestrant
FulvestrantSHR6390 + Fulvestrant

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SHR6390 + FulvestrantExperimentalIntervention Drug: SHR6390, Fulvestrant
  • SHR6390
  • Fulvestrant
Placebo + FulvestrantPlacebo ComparatorIntervention Drug: Placebo, Fulvestrant
  • Placebo
  • Fulvestrant

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, 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.
      
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: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 approximately 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:AEs and SAEs
Time Frame:Up to approximately 24 months.
Safety Issue:
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.
Measure:Ctrough
Time Frame:Up to 4 weeks
Safety Issue:
Description:Ctrough

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

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