breast cancer
Conditions
Interventions
neoadjuvant sequential 4 cycle tri-weekly nanoparticle albumin-bound paclitaxel/Cyclophosphamide (TRI-ABC), with trastuzumab in HER2-positive patients, followed by 4 cycle 5-fluorouracil/epirubicine/c
Sponsors
Dept of surgical oncology, Hiroshima university hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female Histologically confirmed operable invasive breast carcinoma (T1c-3N0-2M0) Age = 20-70 years Evaluated ER and PgR status by IHC Evaluated HER2 status by IHC and/or FISH Adequate left ventricular ejection function (LVEF, >55%) at baseline (by ECHO or MUGA) No prolongation of QTc time (QTc: <470msec) Patient with measurable disease Adequate organ function ECOG Performance Status 0 or 1 Signed written informed consent
Exclusion criteria
Exclusion criteria: Known hypersensitivity to any of study drugs History of receiving any endocrine therapy or chemotherapy for breast cancer within 5 years prior to registration Concurrent, other malignancies Concurrent bilateral breast cancer (except for contra-lateral non-invasive or lobular breast cancer) Male Concurrent, serious or uncontrolled infections Inadequately controlled or serious history of cardiac disease Inadequately controlled diabetes mellitus Concurrent, gastrointestinal ulceration or bleeding Current pregnancy and lactation, or possibility of pregnancy Assessment by investigator that subject unable to comply with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological response clinical response safety relapse-free survival | — |
Countries
Japan
Contacts
Public ContactHideo Shigematsu
Hiroshima university hospital Department of surgical oncology
Outcome results
None listed