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

Primary Purpose

Breast Cancer, Brain Metastases

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib Plus Vinorelbine
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyrotinib plus Vinorelbine

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) of CNS
ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.

Secondary Outcome Measures

Time to progression (TTP)
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)
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 to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.

Full Information

First Posted
April 29, 2019
Last Updated
May 27, 2019
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03933982
Brief Title
A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Acronym
Pyrotinib
Official Title
Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 22, 2018 (Actual)
Primary Completion Date
December 22, 2021 (Anticipated)
Study Completion Date
June 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Brain Metastases
Keywords
Breast cancer, Brain metastases, Pyrotinib, Vinorelbine, HER2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pyrotinib plus Vinorelbine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pyrotinib Plus Vinorelbine
Intervention Description
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 Measure Information:
Title
Objective Response Rate (ORR) of CNS
Description
ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.
Time Frame
Estimated up to 1 year
Secondary Outcome Measure Information:
Title
Time to progression (TTP)
Description
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.
Time Frame
Estimated up to 1 year
Title
OS (overall survival)
Description
OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Time Frame
Estimated up to 1 year
Title
Time to radiotherapy
Description
Time to radiotherapy, defined as the time from the date of informed consent until to the date of radiotherapy.
Time Frame
Estimated up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age18-75 years. ECOG performance status ≤2. Histologically confirmed HER2 positive advanced breast cancer. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.). 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; Signed the informed consent form prior to patient entry. Exclusion Criteria: Participated in other drug clinical trials within 4 weeks before the start of the study; Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study; Received endocrine therapy within 7 days before the start of the study; Suitable for surgical resection; Accompanied by rapid progress of organ invasion; Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.). Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs; Allergies to any compounds of experimental drugs; CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia; Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma. Any other situations judged by investigator as not suitable for participating in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, M.D.
Phone
+8613501270834
Email
yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.
Phone
+8613501270834
Email
yuanpeng01@hotmail.com
Phone
+8615652632903
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name & Degree
Peng Yuan, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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