Breast Cancer
Conditions
Interventions
A:Neoadjuvant chemotherapy regimen containing epirubicin
Sponsors
Department of Breast Surgery, the First Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. by needle or hollow needle aspiration biopsy pathology confirmed to stage II-III Luminal B type (except Her-2 positive) and triple-negative primary breast cancer patients. There are clearly measurable tumor lesions: lesions can be scanned by MRI with diameter> 10 mm; skin nodules with diameter> 10 mm can also be used for measurement; 3. perform further body examination to except metastatic patients; 4. ECOG = 2; 5. blood: hemoglobin =10.0 g/dl, neutrophil count = 1.5 ×10^9/L, platelet count = 90×10^9/L; blood biochemistry: serum total bilirubin = 1.5 ×the limit of normal (ULN), AKP, AST and ALT = 2.5 ×the limit of normal ULN (no demonstrable liver metastases); 6. normal heart function, LVEF = 50%; 7. never received chemotherapyradiotherapy or endocrine therapy; 8. occult breast cancer patients need to be confirmed by pathology; 9. Agree to chemotherapy and surgery and other related treatment, and signed informed consent; 10. Sterilization, postmenopause, or agree to receive medical approved contraceptives during or within 3 month after this trial. Serum or urine pregnancy tests for patients must be negative and non-lactating.
Exclusion criteria
Exclusion criteria: 1. Clinical stage IIA, IIB primary breast cancer patients, without breast-conserving will; 2. Breast biopsy confirmed as Her-2 positive and Luminal A patients; 3. Associated with uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue disease, severe infectious diseases and other diseases; 4. Received chemotherapy, radiotherapy, endocrine therapy; 5. Combined with other malignant tumors, excluding the cured basal cell carcinoma of the skin and cervical in situ cancer; 6. LVEF <50%; 7. Lactation and pregnancy patients; 8. Mental patients or patients with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Burden; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;cCR;cPR;ORR;resection rate;OS;DFS;DDCR; | — |
Countries
China
Contacts
Public ContactJianjun He
Department of Breast Surgery, the First Affiliated Hospital of Xi’an Jiaotong University
Outcome results
None listed