Status:
UNKNOWN
Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Lead Sponsor:
Peking Union Medical College
Conditions:
Breast Cancer
HER2 Gene Mutation
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03412383
Start Date
February 20 2018
End Date
June 25 2019
Last Update
January 30 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fei Ma
Beijing, Beijing Municipality, China, 100021