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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

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ClinicalTrials.gov Identifier: NCT03966898
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: SHR6390 Tablets Drug: Placebo Tablets Drug: Letrozole or Anastrozole Tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SHR6390, Letrozole or Anastrozole
SHR6390, Letrozole or Anastrozole
Drug: SHR6390 Tablets
SHR6390 Tablets

Drug: Letrozole or Anastrozole Tablets
Letrozole or Anastrozole Tablets

Placebo Comparator: Placebo, Letrozole or Anastrozole
Placebo, Letrozole or Anastrozole
Drug: Placebo Tablets
Placebo Tablets

Drug: Letrozole or Anastrozole Tablets
Letrozole or Anastrozole Tablets




Primary Outcome Measures :
  1. 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. ]
    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 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. 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 ]
    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


Other Outcome Measures:
  1. Ctrough [ Time Frame: Up to 4 weeks ]
    To explore the pharmacokinetic characteristics of SHR6390 population and the influencing factors



Information from the National Library of Medicine

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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
  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.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03966898     History of Changes
Other Study ID Numbers: SHR6390-III-302
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 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
Letrozole
Anastrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal