Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
NCT ID: NCT03412383
Last Updated: 2018-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
14 participants
INTERVENTIONAL
2018-02-20
2019-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pyrotinib
Pyrotinib 400mg/day
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
FEMALE
No
Sponsors
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Peking Union Medical College
OTHER
Responsible Party
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Fei Ma
Clinical Professor
Principal Investigators
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Fei Ma
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Fei Ma
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0.
Other Identifiers
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NCC201711008
Identifier Type: -
Identifier Source: org_study_id
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