Breast Cancer
Conditions
Interventions
Experimental:pegylated liposomal doxorubicin(PLD) 35 mg/m2 plus cyclophosphamide (CTX) 600 mg/m2, every 21 days for 4 cycles.
Comparator:epirubicin 90 mg/m2 plus cyclophosphamide (CTX) 600 mg/m2, every 21 days for 4 cycles.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patients signed the written informed consent; 2. Female patient aged 18 to 70 years; 3. The patients with histological proof of operable invasive breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging; 4. The patients have no treatment history of breast cancer; 5. The patients' ECOG scores are =2; 6. The patients have normal cardiac functions by echocardiography(LVEF=50%) and no cardiac pathology(=NYHA II); 7. The results of patients' blood tests are as follows: Hb=90g/L; WBC=3.5×10^9/L; Plt=100×10^9/L; Neutrophils=1.5×10^9/L; ALT and AST = triple of normal upper limit; TBIL and Creatinine = 1.5 times of normal upper limit.
Exclusion criteria
Exclusion criteria: 1. The patients have other cancers at the same time or have the history of other cancers within 5 years, except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus; 2. The patients have bilateral breast cancers or inflammatory breast cancers or metastatic breast cancer; 3. Pregnant, lactating women, or women who have fertility but havent taken contraceptive measures; 4. The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials; 5. The patients have allergic history or contraindication of any of the interventional drugs; 6. The patients have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease or congenital heart disease; 7. The patients have active infections that were not suitable for chemotherapy; 8. The patients have severe non-cancerous diseases, which may affect the patient's compliance or put the patient in danger; 9. The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (RECIST 1.1) at the end of neoadjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate;The incidence of cardiotoxicity;Number of participants with treatment-related adverse events as assessed by CTCAE v4.0;QOL score change in relation to neoadjuvant therapy;Peripheral blood T cell subsets percentage change and tumor specific T cell (CTL) activity change in relation to neoadjuvant therapy; | — |
Countries
China
Contacts
Public ContactErwei Song
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed