Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
- Conditions
- HER2 Gene MutationBreast Cancer
- Registration Number
- NCT03412383
- Lead Sponsor
- Peking Union Medical College
- Brief Summary
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 14
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) up to 36 months 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
Name Time Method Adverse events (AEs) up to 36 months Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
Overall Response rates (ORR) up to 36 months 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) up to 36 months 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) up to 36 months Time from first use Pyrotinib to disease progression
Quality of Life(QoL) up to 36 months Using the EORTC quality of life questionnaire QLQ-C30
Overall survival (OS) up to 52 months Time from first use Pyrotinib to death
Trial Locations
- Locations (1)
Fei Ma
🇨🇳Beijing, Beijing, China