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Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993964
Recruitment Status : Unknown
Verified June 2019 by wang shusen, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
wang shusen, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Estimated Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
Objective Response Rate [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 100 months ]
CR+PR
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • PFS [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 100 months ]
    Progression-Free Survival
  • OS [ Time Frame: from enrollment to death (for any reason).assessed up to 100 months ]
    Overall Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
Official Title  ICMJE A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With CDK4/6 Inhibitor SHR6390 in Treatment of HER2-positive Metastatic Breast Cancer
Brief Summary The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE Drug: Pyrotinib combine with SHR6390
SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway. Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic breast cancer
Study Arms  ICMJE Experimental: Experimental: Pyrotinib + SHR6390
Pyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd
Intervention: Drug: Pyrotinib combine with SHR6390
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
  • HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
  • Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
  • 18-70 years old.
  • ECOG PS 0~1.
  • life expectancy is not less than 12 weeks.
  • at least one measurable lesion according to RECIST 1.1.
  • ANC ≥ 2.0×109/L,PLT ≥ 100×109/L,Hb ≥ 90 g/L;TBIL≤1.5ULN;ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis);BUN and Cr≤1.5×ULN
  • LVEF ≥ 50% and QTc≤470 ms.

Exclusion Criteria:

  • Patients with symptomatic brain metastasis;
  • Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
  • patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
  • Participated in other drug clinical trials within 4 weeks before admission
  • Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
  • Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
  • A history of immunodeficiency, including HIV positive, HCV,, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
  • Has suffered from any heart disease
  • Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
  • According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
  • Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever(> 38.5 ℃) of unknown origin occurs during the screening period/before the first administration.
  • Researchers believe that patients are not suitable for any other situation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993964
Other Study ID Numbers  ICMJE HR-BLTN-014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party wang shusen, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP