breast cancer
Conditions
Interventions
neoadjuvant sequential 4 cycle nab-paclitaxel tri-weekly, with trastuzumab in HER2-positive patients, followed by 4 cycle 5-fluorouracil/epirubicine/cyclophosphamide (FEC) tri-weekly nab-paclitaxel
Sponsors
Yokkaichi Municipal Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed operable breast c ancer 2)Clinical stage 1, 2, 3 3)Operable breast cancer in neoadjuvant setting 4)Over 20 year-old female 5)Previously untreated by operation, radiotherapy, chemotherapy, endocrine therapy 6)Exhibited adequate organ function 7)Performance status(PS) 0-1 8)Signed written informed consent
Exclusion criteria
Exclusion criteria: 1)Known hypersensitivity to human serum alb umin 2)Concurrent, serious or uncontrolled infect ions 3)Inadequately controlled or serious history of cardiac disease 4)Confirmed symptomatic brain metastasis 5)Current pregnancy and lactation, or possib ility of pregnancy 6)Known drug allergy to any of study drugs 7)Assessment by investigator that subject un able to comply with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) Safety | — |
Countries
Japan
Contacts
Public ContactYutaka Mizuno
Yokkaichi Municipal Hospital Department of breast surgery
Outcome results
None listed