Breast cancer
Conditions
Interventions
Experimental group:Pyrotinib 400mg, q3w
Sponsors
The First People's Hospital of Lianyun'gang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female patients, >= 18 years old, who are newly diagnosed breast cancer; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 3. Histologically confirmed invasive breast cancer with primary tumors larger than 2 cm in diameter; 4. Patients were HER2-positive by immunohistochemistry (IHC 3+) or by fluorescence in situ hybridisation (mandatory for IHC2+ tumors); 5. Adequate bone marrow, kidney and hepatic function; 6. If a patient is of childbearing potential the patient must agree to use effective contraception during the study and for 7 months after the last dose of study drug; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Stage IV breast cancer; 2. Major surgery within 28 days of study entry; 3. Any known drug allergy. Known positive HIV testing; 4. Pregnant or breast feeding patients; 5. Not suitable for the trial considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR(Pathologic Complete Response); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival;Disease-Free Survival;Distant Metastasis-Free Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZhou Jun
The First People's Hospital of Lianyun'gang
Outcome results
None listed