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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993964
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Pyrotinib combine with SHR6390 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With CDK4/6 Inhibitor SHR6390 in Treatment of HER2-positive Metastatic Breast Cancer
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Experimental: Pyrotinib + SHR6390
Pyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd
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




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: from enrollment to progression or death (for any reason), assessed up to 100 months ]
    CR+PR


Secondary Outcome Measures :
  1. PFS [ Time Frame: from enrollment to progression or death (for any reason),assessed up to 100 months ]
    Progression-Free Survival

  2. OS [ Time Frame: from enrollment to death (for any reason).assessed up to 100 months ]
    Overall Survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: wang shusen, clinical professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03993964    
Other Study ID Numbers: HR-BLTN-014
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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