Breast Cancer
Conditions
Interventions
Observation group:None
Sponsors
People's Hospital of Nanchang City
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years and above, female; 2. Patients with treatment-naïve primary invasive breast cancer with histopathological diagnosis of HER2 positive (except occult breast cancer, inflammatory breast cancer and eczema-like cancer); 3. The diameter of the primary tumor determined by the local standard assessment method > 2 cm; Tumor stage: early (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, all N, M0), patients who require neoadjuvant therapy and undergo surgery, and neoadjuvant therapy uses HP regimens; 4. According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, with at least one evaluable target lesion; 5. ECOG physical fitness score 0~1 points; 6. For female patients who are not menopausal or surgically sterilized: agree to use contraception during the treatment period and for at least 7 months after the last dose of study treatment; 7. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to the active ingredients or other ingredients of the study drug; 2. Those who do not require neoadjuvant therapy; 3. Pregnant or lactating women, women of childbearing age who refuse to take effective contraceptive measures during the study; 4. Those who need to receive other anti-tumor therapy (except ovarian function inhibitors) as judged by the investigator and are not suitable for inclusion; 5. Serious or uncontrolled infections that may affect the study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, positive human immunodeficiency virus (HIV) antibodies, lung infection, etc.; 6. Mental illness, cognitive impairment, inability to understand the research protocol and side effects, and inability to complete the research protocol and follow-up workers; 7. The patient has any other condition that the investigator considers unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR after neoadjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Different populations (HR status) pCR after neoadjuvant therapy;Adverse event rates;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactNiu Fan /Cao Yali
People's Hospital of Nanchang City
Outcome results
None listed