breast cancer
Conditions
Interventions
Administrate 4 cycles of dose dense EC therapy(Epirubicine and Cyclophosphamide) followed by 4 cycles of nab-PTX. Operation is to be performed after chemotherapy. EC(, Epirubicin 90mg/m2, Cyclopho
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (T2-4 any N M0) 2)luminal B(ER positive,Ki67index>=20%) or Triple negative(ER negative PgR negative HER2 negative) 3)Age between 20 to 75 years old 4)ECOG performance status (PS): 0-1 5)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 6)Results from a laboratory test meet the following: a)Leukocyte count is >=3000/mm3 or b)Neutrophil count is >=2000/mm3 c)Hemoglobin >=9.0g/dL d)Platelet >=100 000/mm3 e)AST and ALT <=x 2.0 of upper limit of normal (ULN) f)Bilirubin (total bilirubin or direct bilirubin) <=1.5 of ULN g)Serum creatinine <=x 1.5 of ULN 7)Signed written informed consent
Exclusion criteria
Exclusion criteria: 1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding). 2)Multiple primary cancer 3)Synchronous bilateral breast cancer 4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 5)Women who are pregnant, lactating or with childbearing potential 6)Hypersensitivity to any agents necessary in the planned treatment. 7)Serious peripheral neuropathy or serious edema 8)Pleural effusion or cardiac effusion which requires treatment 9)Complication which requires prior treatment with corticosteroid 10)Suspected infection 11)Ineligible based on decision of an investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate the rates of breast conserving surgery dosease free survival overall survival side effects | — |
Countries
Japan
Contacts
Public ContactAyana Sakuramachi
Kyoto Prefectural University of Medicine Endocrine & Breast Surgery
Outcome results
None listed