"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

September 30, 2019

Study Completion Date

November 30, 2019

Conditions
Breast Neoplasms
Interventions
DRUG

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

DRUG

Pertuzumab

Pertuzumab (840 mg as an i.v. infusion) will be given on day 1 q. 3 weeks for a total of 6 administration

DRUG

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

DRUG

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

Trial Locations (7)

16132

IST San Martino, Genova

20100

Ospedale San Raffaele, Milan

20141

Istituto Europeo di Oncologia, Milan

33100

Ospedale Santa Maria della Misericordia, Udine

40138

Policlinico Sant'Orsola Malpighi, Bologna

42123

Arcispedale S.Maria Nuova A.O.Reggio Emilia, Reggio Emilia

44124

Azienda Ospedaliero Universitaria di Ferrara - Arcispedale S. Anna, Ferrara

All Listed Sponsors
lead

Fondazione Michelangelo

OTHER

NCT02530424 - "Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment " | Biotech Hunter | Biotech Hunter