The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab
Istituto Nazionale per La Ricerca sul Cancro (IST)
Genoa, Ge, Italy
Ospedale S. Maria della Misericordia - Oncologia Medica
Perugia, PG, Italy
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
Candiolo, TO, Italy
Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica
Torino, To, Italy
pathologic complete response
Time frame: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
safety and tolerability
safety and tolerability will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Toxicity grade is defined by the NCI Common Toxicity Criteria (CTC) Adverse Event (AE) v 3.0
Time frame: one year
cardiotoxicity
Time frame: one year
disease free survival
Time frame: one year
overall survival
Time frame: one year
rate of conversion from radical to conservative surgery
Time frame: definitive surgery
potential biomarkers of trastuzumab resistance
Time frame: one year
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Ospedale Mauriziano Umberto I - Ginecologia Oncologica
Torino, TO, Italy
Ospedale Sacro Cuore - Don Calabria - Oncologia Medica
Negrar, VR, Italy