102
Participants
Start Date
May 31, 2015
Primary Completion Date
September 30, 2019
Study Completion Date
November 30, 2019
Trastuzumab
Trastuzumab (8 mg/kg loading dose IV, then 6 mg/kg IV) will be given on day 1 q. 3 weeks for a total of 6 administrations
Pertuzumab
Pertuzumab (840 mg as an i.v. infusion) will be given on day 1 q. 3 weeks for a total of 6 administration
Palbociclib
Palbociclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks (i.e. 1 week rest period for a total of 5 cycles
Fulvestrant
Fulvestrant will be administered according to local prescription guidelines and will be given intra-muscle at the dose of 500 mg every 4 weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose
IST San Martino, Genova
Ospedale San Raffaele, Milan
Istituto Europeo di Oncologia, Milan
Ospedale Santa Maria della Misericordia, Udine
Policlinico Sant'Orsola Malpighi, Bologna
Arcispedale S.Maria Nuova A.O.Reggio Emilia, Reggio Emilia
Azienda Ospedaliero Universitaria di Ferrara - Arcispedale S. Anna, Ferrara
Fondazione Michelangelo
OTHER