breast cancer
Conditions
Interventions
Triweekly nab-paclitaxel followed by EC as Neoadjuvant chemotherapy.Nab-paclitaxel regimen 260mg/m2 iv day 1 Q3weeks of each 4 cycles.EC regimen Epirubicin 90mg/m2 iv day 1.Cyclophosphamide 600mg/m
Sponsors
Tokyo Women's Medical University,Department of endocrine surgery
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female resectable breast cancer (T1c-3N0-2M0) Histologically confirmed invasive breast cancer by biopsy.Evaluated ER and PgR status by IHC. Evaluated ER and PgR status by FISH.20 to 79 years old at diagnosis. Adequate major organ function. LVEF > 50% (by MUGA or ECHO).QTc < 470mec (by ECG). Performance status(ECOG) should be 0 or 1. Written informed consent.
Exclusion criteria
Exclusion criteria: History of drug-hypersensitivity. No previous treatments for breast cancer (within 5 years) . Active double cancer. Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). Male patient. Infection or suspected infection. Serious cardiac disorder or preexisting cardiac disease. Uncontrolled diabetes. Gastrointestinal ulceration or gastrointestinal bleeding Current pregnancy and lactation, or possibility of pregnancy. Ineligible based on decision of an investigator. preexisting cardiac disease. Uncontrolled diabetes. Gastrointestinal ulceration or gastrointestinal bleeding. Current pregnancy and lactation, or possibility of pregnancy. Ineligible based on decision of an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate Safety Breast conservation rate Disease-free survival | — |
Countries
Japan
Contacts
Public ContactAkiko Sakamoto
Tokyo Women's Medical University Department of Endocrine Surgery
Outcome results
None listed