Breast cancer
Conditions
Interventions
Preoperative chemotherapy with nab-paclitaxel(with or without Trastuzumab) therapy 4 courses followed by Anthracycline based regimen four courses, to perform the surgery
Sponsors
SHINKO HOSPITAL
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)female breast cancer histologically diagnosed primary invasive breast cancer 2)stage2-3A 3) radical resection can be expected by preoperative chemotherapy and surgery 4)patients with measurable lesions 5)diagnosed ER-negative 6)20 years old or older, 75 years old or younger 7)performance Status (PS) 0-1 8)no previous treatment, surgery, radiation therapy, chemotherapy, endocrine therapy 9) LVEF values is determined to be proper (> 50%) by echocardiography or MUGA 10)major organ function is sufficiently held in the clinical examination of the registration within 14 days prior 11)consent is obtained from the patient himself in writing for the test participation
Exclusion criteria
Exclusion criteria: 1)patients with previous treatment history of nab-paclitaxel 2)active double cancer (synchronous double cancer and metachronous double cancer disease-free period is within 5 years) 3)serious complications (congestiveheart failure, coronary insufficiency, heart disease such as a myocardial infarction and angina pectoris and Arrhythmia requiring treatment, history of cerebrovascular disease, gastrointestinal ulcer bleeding or requiring treatment, control bad diabetes, renal failure, active hepatitis and cirrhosis, liver failure, etc.) 4)has a fever, suspected infection 5)pleural effusion requiring treatment, pericardial effusion example 6)a clear interstitial pneumonia or pulmonary fibrosis in the chest X photos and chest CT 7)a history of drug hypersensitivity 8)a history of severe hypersensitivity for the components of the therapeutic agent (nab-paclitaxel) 9) a possibility of pregnancy and pregnancy, or breast-feeding 10)history of serious mental illness or are under treatment, patients judged that the participation in examination is difficult 11)HBs antigen-positive 12)Other cases of the physician has determined to be inappropriate as a target
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Countries
Japan
Contacts
Public ContactKazuhiko Yamagami
SHINKO HOSPITAL Department of Breast Surgery
Outcome results
None listed