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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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ClinicalTrials.gov Identifier: NCT03927456
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 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
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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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
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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
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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
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No Contacts or Locations Provided
More Information
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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: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs