Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Study Overview
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Brief Summary
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A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Official Title
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A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

Conditions
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Breast Cancer, HER2 Gene Mutation

Intervention / Treatment
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* Drug: Pyrotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pyrotinib|Pyrotinib 400mg/day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) | up to 36 months | 
| 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. | up to 36 months | 
| 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. | up to 36 months | 
| Time to Progression (TTP) | Time from first use Pyrotinib to disease progression | up to 36 months | 
| Quality of Life(QoL) | Using the EORTC quality of life questionnaire QLQ-C30 | up to 36 months | 
| Overall survival (OS) | Time from first use Pyrotinib to death | up to 52 months |