breast cancer
Conditions
Interventions
neoadjuvant sequential 4cycle nab-paclitaxel tri-weekly, with trastuzumab, pertuzumab in HER2-positive patients, followed by 4 cycle dose dense epirubicine/cyclophosphamide (ddEC) tri-weekly nab-p
Sponsors
Breast Surgery, 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, under 75 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 |
|---|---|
| Pathological complete response (pCR) in breast and axillary lymph node | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events with nab-paclitaxel and ddEC therapy | — |
Countries
Japan
Contacts
Public ContactYutaka Mizuno
Yokkaichi Municipal Hospital Breast Surgery
Outcome results
None listed