breast cancer
Conditions
Interventions
Patients receive nab-paclitaxel 260 mg/m2 intravenously on a 21-day schedule for 4 cycles. After that, patients receive epirubicin 100mg/2, fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 intrav
Sponsors
kyushu Breast Cancer Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Histologically confirmed breast cancer Clinical stage I - IIIB (T1-3, N0-2, M0) ER, PgR and HER2 status are confirmed Having measurable lesion according to RECIST version 1.1 No previous treatment for breast cancer Having Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Having adequate organ function Providing written informed consent for this trial
Exclusion criteria
Exclusion criteria: Having significant cardiovascular disease and a history of that Having significant complications such as uncontrolled hypertension and diabetes mellitus, renal failure, liver failure, clinically significant infection and mental disorder Pregnant, breast feeding and case of possibility of pregnancy Bilateral breast cancer with concurrent or metachronism Pulmonary fibrosis or interstitial pneumonia Having a known hypersensitivity to the components of the study therapy Cases judged unsuitable by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pathological complete response (pCR rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast-conserving surgery (BCS) rate, objective response rate (ORR), safety, disease-free survival, overall survival, pCR rates, ORR and BCS rates based on subtype. ORR and safety during nab-paclitaxel treatment. | — |
Countries
Japan
Contacts
Public ContactKazuo Tamura
Clinical Hematology Oncology Treatment Study Group Kyushu Breast Cancer Study Group
Outcome results
None listed