HER2 positive breast cancer
Conditions
Interventions
Case series:None
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the study and sign the informed consent form; 2. Female breast cancer patients aged =18 years old and =80 years old; 3.Eastern Cooperative Oncology Group (ECOG) performance status = 2; 4.Patients with breast cancer are eligible: (1) histologically or pathologically diagnosed resectable invasive breast cancer; the primary tumor stage is cT1-4/N0-3/M0 according to standard evaluation at the study site; (2) HER2-positive breast cancer confirmed by a central laboratory and defined as: IHC 3+ in > 10% immunoreactive cells OR c-erbB2 gene amplification by in situ hybridization [ISH] (ratio of c-erbB2 gene signals to centromere 17 signals = 2 or HER 2 gene copy number =6); (3) known hormone receptor status (ER and PgR); 5. For premenopausal or surgically sterilized women: Contraception must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment; 6.Life expectancy =3 months.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) or inflammatory breast cancer; 2. Any malignant tumor other than breast cancer; 3. Sensitivity to any of the study medications or any of the ingredients or excipients of these medications; A history of immunodeficiency, including testing positive for HIV or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; 4. Any known liver disease, including infectious disease with active infection, autoimmune liver disease, and sclerosing cholangitis; 5. Pregnant or lactating women or women of childbearing potential without a negative pregnancy test (serum) at baseline; 6. Any other circumstances considered by the investigator to be inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| bpCR;Disease-free survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactXie Shaoli
Affiliated Hospital of North Sichuan Medical college
Outcome results
None listed