Breast cancer
Conditions
Interventions
Case group:None. This was a real-world study in which investigators selected first-line trastuzumab and pertuzumab combined with chemotherapy according to clinical practice and guideline recommendatio
Sponsors
The Second Qilu Hospital of Shandong University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily enroll in this study and sign the informed consent form; 2.Female patients with breast cancer aged >=18 years and =1.5 × 10^9/L; platelet count >= 90 × 10^9/L; hemoglobin >=90 g/L;b. Blood biochemistry: total bilirubin = upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase= 50 mL/min;c. Echocardiography: left ventricular ejection fraction >=55%;d. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 msec; 8.For premenopausal or non-surgically sterilized female patients: agree to practice abstinence or use effective contraception during treatment and for at least 7 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1.History of any other prior malignancy; 2.Underwent major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or has not fully recovered from such surgery; 3.Presence of severe comorbidities (including but not limited to severe cardiac disease or dysfunction) or other concurrent medical conditions that would interfere with the planned treatment; 4.Known hypersensitivity to any of the study drug components, history of immunodeficiency including positive HIV test, other acquired or congenital immunodeficiency disorders, or history of organ transplantation; 5.Female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival;Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Safety Analysis;Cost-Effectiveness Ratio;Incremental Cost-Effectiveness Ratio; | — |
Countries
China
Contacts
Public ContactLixiang Yu
The Second Qilu Hospital of Shandong University
Outcome results
None listed