HER2-positive breast cancer
Conditions
Interventions
HER-2 positive early or locally advanced breast cancer patients observation group:None
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years old and above, female; 2.Patients with treatment-naïve primary invasive breast cancer confirmed by histopathology who are positive for HER2 (except occult breast cancer, inflammatory breast cancer and eczema-like cancer); 3.The diameter of the primary tumor as determined by the local standard evaluation method > 2 cm; Tumor stage: early (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, all N, M0), those who have been identified for neoadjuvant therapy with HP-containing regimens; 4.According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there is at least one evaluable target lesion; 5.ECOG physical condition score of 0~1 points; 6.For female patients who are not postmenopausal or surgically sterilized: during the treatment period and for at least 7 months after the last dose in the study treatment, agree to contraception; 7.Voluntarily join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity to the active ingredient or other ingredients of the study drug; 2.those who do not require neoadjuvant therapy; 3.Pregnant or lactating females, females of childbearing potential who refuse to take effective contraceptive measures during the study; 4.Pregnant or lactating females, females of childbearing potential who refuse to take effective contraceptive measures during the study; 5.Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc; 6.Workers with mental illness, cognitive impairment, inability to understand the study protocol and side effects, inability to complete the study protocol and follow-up workers; 7.Patient has any other condition that, in the opinion of the investigator, is not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients were evaluated for postoperative pCR after neoadjuvant therapy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of all adverse events and serious adverse events during the study period was analyzed;Postoperative pCR with different neoadjuvant regimens; | — |
Countries
China
Contacts
Public ContactWang Yongsheng
Cancer Hospital Affiliated to Shandong First Medical University
Outcome results
None listed