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

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: NCT03933982
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933982


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

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Responsible Party: Peng Yuan, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03933982    
Other Study ID Numbers: NCC1865
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 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
Keywords provided by Peng Yuan, Chinese Academy of Medical Sciences:
Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vinorelbine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action