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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03933982

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 29, 2019

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:Breast Cancer
    Brain Metastases
  • Intervention/Treatment: Drug: Pyrotinib Plus Vinorelbine
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • 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 2018
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: June 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
  • Ages Eligible for Study: 18 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

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

Locations

China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Study Chair: Peng Yuan, M.D. Cancer Institute and Hospital, Chinese Academy of Medical Sciences

More Information
  • Responsible Party: Chinese Academy of Medical Sciences
  • ClinicalTrials.gov Identifier: NCT03933982 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Chinese Academy of Medical Sciences: Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2
  • Additional relevant MeSH terms: Breast Neoplasms
    Neoplasm Metastasis
    Neoplasms, Second Primary
    Brain Neoplasms