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出境医 / 临床实验 / A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer (Pyrotinib)

A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer (Pyrotinib)

Study Description
Brief Summary:
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Brain Metastases Drug: Pyrotinib Plus Vinorelbine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study
Actual Study Start Date : December 22, 2018
Estimated Primary Completion Date : December 22, 2021
Estimated Study Completion Date : June 22, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Pyrotinib plus Vinorelbine Drug: Pyrotinib Plus Vinorelbine
Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.
Outcome Measures
Primary Outcome Measures :
  1. Objective Response Rate (ORR) of CNS [ Time Frame: Estimated up to 1 year ]
    ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.


Secondary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: Estimated up to 1 year ]
    TTP, defined as the time from the date of informed consent until the date of disease progression (PD), either CNS PD or extracranial PD, whichever comes first.

  2. OS (overall survival) [ Time Frame: Estimated up to 1 year ]
    OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.

  3. Time to radiotherapy [ Time Frame: Estimated up to 1 year ]
    Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.


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. Age18-75 years.
  2. ECOG performance status ≤2.
  3. Histologically confirmed HER2 positive advanced breast cancer.
  4. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
  5. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
  6. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
  7. Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm;
  8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

  1. Participated in other drug clinical trials within 4 weeks before the start of the study;
  2. Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
  3. Received endocrine therapy within 7 days before the start of the study;
  4. Suitable for surgical resection;
  5. Accompanied by rapid progress of organ invasion;
  6. Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.).
  7. Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs;
  8. Allergies to any compounds of experimental drugs;
  9. CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia;
  10. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma.
  11. Any other situations judged by investigator as not suitable for participating in this study.
Contacts and Locations

Contacts
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Contact: Peng Yuan, M.D. +8613501270834 yuanpeng01@hotmail.com

Locations
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China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Peng Yuan, M.D.    +8613501270834    yuanpeng01@hotmail.com   
Contact    +8615652632903    yuanpeng01@hotmail.com   
Principal Investigator: Peng Yuan, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Chair: Peng Yuan, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE December 22, 2018
Estimated Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		Objective Response Rate (ORR) of CNS [ Time Frame: Estimated up to 1 year ]
ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Time to progression (TTP) [ Time Frame: Estimated up to 1 year ]
    TTP, defined as the time from the date of informed consent until the date of disease progression (PD), either CNS PD or extracranial PD, whichever comes first.
  • OS (overall survival) [ Time Frame: Estimated up to 1 year ]
    OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
  • Time to radiotherapy [ Time Frame: Estimated up to 1 year ]
    Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.
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 A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Official Title  ICMJE Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study
Brief Summary Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from 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
  • Breast Cancer
  • Brain Metastases
Intervention  ICMJE Drug: Pyrotinib Plus Vinorelbine
Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.
Study Arms  ICMJE Experimental: Pyrotinib plus Vinorelbine
Intervention: Drug: Pyrotinib Plus Vinorelbine
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 22, 2022
Estimated Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age18-75 years.
  2. ECOG performance status ≤2.
  3. Histologically confirmed HER2 positive advanced breast cancer.
  4. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
  5. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
  6. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
  7. Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm;
  8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

  1. Participated in other drug clinical trials within 4 weeks before the start of the study;
  2. Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
  3. Received endocrine therapy within 7 days before the start of the study;
  4. Suitable for surgical resection;
  5. Accompanied by rapid progress of organ invasion;
  6. Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.).
  7. Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs;
  8. Allergies to any compounds of experimental drugs;
  9. CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia;
  10. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma.
  11. Any other situations judged by investigator as not suitable for participating in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peng Yuan, M.D. +8613501270834 yuanpeng01@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933982
Other Study ID Numbers  ICMJE NCC1865
Has Data Monitoring Committee No
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 Peng Yuan, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Peng Yuan, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Chinese Academy of Medical Sciences
Verification Date May 2019

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

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