49
Participants
Start Date
December 17, 2014
Primary Completion Date
October 31, 2018
Study Completion Date
March 17, 2020
Liposomal doxorubicin
50 mg/m2 by intravenous infusion over a period of 1 hour on day 1 of each cycle repeated every 21 days. A final concentration of between 0.4 to 1.2 mg/ml doxorubicin hydrochloride, is required
Docetaxel
30 mg/m2 by intravenous infusion over a period of 1 hour on day 2 and 9, every 3 week.They will be given for 6 cycles.
Trastuzumab
4 mg/kg for the first administration (day 2 cycle 1) and 2 mg/kg for subsequent administrations. Trastuzumab will be given weekly for the duration of chemotherapy (day 2, 9, 16), then will be administered at the dose of 6 mg/Kg every 3 weeks until completion of 52 weeks of treatment.
Metformin
It is administered as single agent from day -13 to 0. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10, Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.
Oncologia Medica Ospedale Guglielmo da Saliceto, Piacenza
Oncologia Medica AUSL Imola, Imola
Oncologia Medica, Policlinico di Modena, Modena
Day Hospital Oncologico, Ospedale Guastalla, Guastalla
Oncologia , IRCCS azienda ospedaliera S.Maria Nuova, Reggio Emilia
Oncologia Medica AOU Parma, Parma
Oncologia Medica AOU Ferrara, Ferrara
IRST Oncologia medica, Meldola
U.O Oncologia AUSLdella Romagna, Rimini
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER