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

  • Clinicaltrials.gov identifier

    NCT03927456

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    June 3, 2021

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:Advanced Breast Cancer
  • Intervention/Treatment: Drug: SHR6390
    Drug: Placebo
    Drug: Fulvestrant
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 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

  • Ages Eligible for Study: 18 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

Contacts

Locations

China, Beijing
Chinese Academy of Medical Science
Beijing

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

More Information

  • Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03927456 History of Changes
  • Other Study ID Numbers: SHR6390-III-301
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: June 3, 2021
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms