Back to resultsPyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Primary Purpose
Breast Cancer, HER2 Gene Mutation
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document.
At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV.
There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)>70, life expectancy > 12 weeks
Exclusion Criteria:
Lack of adequate organ function as defined below within 2 weeks of registration:
Absolute neutrophil count (ANC)<1.5×109/L，platelet counts (PLT)<75×109/L or hemoglobin (Hb)<100g/L Total bilirubin (TBiL)>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5×ULN（or>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)>2.5×ULN; serum creatinine concentration (Scr)>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.
Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy.
Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail
Sites / Locations
- Fei MaRecruiting
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
From date of first use Pyrotinib until the date of first documented progression or date of death from any cause, whichever came first
Secondary Outcome Measures
Adverse events (AEs)
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
Overall Response rates (ORR)
Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Clinical Benefit rate (CBR)
Defined as CR+PR+stable disease (SD), assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Time to Progression (TTP)
Time from first use Pyrotinib to disease progression
Quality of Life(QoL)
Using the EORTC quality of life questionnaire QLQ-C30
Overall survival (OS)
Time from first use Pyrotinib to death
Full Information
NCT ID
NCT03412383
First Posted
January 14, 2018
Last Updated
January 28, 2018
Sponsor
Peking Union Medical College
1. Study Identification
Unique Protocol Identification Number
NCT03412383
Brief Title
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Official Title
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Anticipated)
Primary Completion Date
January 25, 2019 (Anticipated)
Study Completion Date
June 25, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College
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
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, HER2 Gene Mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pyrotinib
Intervention Description
Pyrotinib 400mg/day
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
From date of first use Pyrotinib until the date of first documented progression or date of death from any cause, whichever came first
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
Adverse events (AEs)
Description
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
Time Frame
up to 36 months
Title
Overall Response rates (ORR)
Description
Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Time Frame
up to 36 months
Title
Clinical Benefit rate (CBR)
Description
Defined as CR+PR+stable disease (SD), assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Time Frame
up to 36 months
Title
Time to Progression (TTP)
Description
Time from first use Pyrotinib to disease progression
Time Frame
up to 36 months
Title
Quality of Life(QoL)
Description
Using the EORTC quality of life questionnaire QLQ-C30
Time Frame
up to 36 months
Title
Overall survival (OS)
Description
Time from first use Pyrotinib to death
Time Frame
up to 52 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document.
At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV.
There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)>70, life expectancy > 12 weeks
Exclusion Criteria:
Lack of adequate organ function as defined below within 2 weeks of registration:
Absolute neutrophil count (ANC)<1.5×109/L，platelet counts (PLT)<75×109/L or hemoglobin (Hb)<100g/L Total bilirubin (TBiL)>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5×ULN（or>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)>2.5×ULN; serum creatinine concentration (Scr)>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.
Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy.
Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Ma, MD
Phone
+86-10-87787652
Email
mafei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Ma
Organizational Affiliation
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fei Ma
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Ma, MD
Phone
+86-10-87787652
Email
mafei@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
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