Breast Cancer, HER2 Gene Mutation
Conditions
Brief summary
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Interventions
DRUGPyrotinib
Pyrotinib 400mg/day
Sponsors
Peking Union Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Adverse events (AEs) | up to 36 months | Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0) |
| 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 |
| Time to Progression (TTP) | up to 36 months | Time from first use Pyrotinib to disease progression |
Countries
China
Contacts
Primary ContactFei Ma, MD
Outcome results
None listed