Breast Cancer
Conditions
Brief summary
Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients
Interventions
DRUGDoxorubicin Hydrochloride Liposome injection and cyclophosphamide
DRUGpirarubicin and cyclophosphamide
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with age between 18 and 70 years. * Newly diagnosed breast cancer, stages IIb-IIIc. * KPS performance status≥70. * Measurable disease according to RECIST version 1.1. * Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%. * Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L). * Adequate hepatic and renal function. * AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal. * Serum creatinine≥44 µmol/L and ≤133 µmol/L. * Written informed consent are acquired. * Not in pregnancy or the pregnancy tests of females is negative.
Exclusion criteria
* Severe heart failure (NYHA grade II or higher). * Active and uncontrolled severe infection. * Have accepted any other anti-tumor drug within 30 days before the first dose or * received radiation treatment. * Other situations that investigators consider as contra-indication for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response | until the completion of 4 cycles (each cycle is 21 days) of chemotherapy |
Countries
China
Contacts
Primary ContactGeng Cuizhi, archiater
Outcome results
None listed