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

NCT03966898

Description:

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.

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 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

Clinical Trial IDs

  • ORG STUDY ID: SHR6390-III-302
  • NCT ID: NCT03966898

Conditions

  • Advanced Breast Cancer

Interventions

DrugSynonymsArms
SHR6390 TabletsSHR6390, Letrozole or Anastrozole
Placebo TabletsPlacebo, Letrozole or Anastrozole
Letrozole or Anastrozole TabletsSHR6390, Letrozole or Anastrozole

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SHR6390, Letrozole or AnastrozoleExperimentalSHR6390, Letrozole or Anastrozole
  • SHR6390 Tablets
  • Letrozole or Anastrozole Tablets
Placebo, Letrozole or AnastrozolePlacebo ComparatorPlacebo, Letrozole or Anastrozole
  • Placebo Tablets
  • Letrozole or Anastrozole Tablets

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

          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.
      
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: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.
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 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: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
Safety Issue:
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

Details

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

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