early breast cancer
Conditions
Interventions
Administrate 4 cycles of nab-Paclitaxel and S-1 therapy. Nab-paclitaxel (220 mg/m2) intravenously on day 1 of each 3 weeks.S-1 given orally twice daily for 14 consecutive days, followed by a 7-day
Sponsors
The University of Tokushima Graduate School
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 (Stage IIA-Stage IV)and tumor size is 2cm or larger. (2)Age between 20 to 75 years old. (3)ECOG performance status (PS):0-1 (4)A survival expectancy of 6 months or longer. (5)Results from a laboratory test meet the following A)Leukocyte count is >=3,500/mm3 and <=12,000/mm3 B)Neutrophil count is >=2000/mm3 C)Platelet >=100,000/mm3 D)Hemoglobin >=9g/dl E)Serum creatinine <= *2 of ULN F)Ccr>=60ml/min G)Total bilirubin <= 1.5mg/dl H)AST/ALT <= *1.5 of ULN (6)Signed written informed concent.
Exclusion criteria
Exclusion criteria: (1)DCIS or breast cancer wiht micro invasion. (2)Patients with contraindication for any agents necessary in the planned treatment (3)Male (4)Women who are pregnant, lactating or with childbearing potential. (5)Patients with a history of chemotherapy, endocrinetherapy or radiotherapy. (6)Multiple primary cancer. (7)Serious complications(diabetes infection or mental disorder) (8)Serious complications with cardiac function (9)Patients with serious edema (10)Hypersensitivity to any agents necessary in the planned treatment. (11)Ineligible based on decision of a investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate (ypT0/is ypN0) | — |
Countries
Japan
Contacts
Public ContactMasami Morimoto
The University of Tokushima Graduate School Depertment of Thoracic, Endocrine surgery and Oncology
Outcome results
None listed