A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

December 17, 2014

Primary Completion Date

October 31, 2018

Study Completion Date

March 17, 2020

Conditions
HER-2 Positive Breast Cancer
Interventions
DRUG

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

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (9)

29121

Oncologia Medica Ospedale Guglielmo da Saliceto, Piacenza

40133

Oncologia Medica AUSL Imola, Imola

41100

Oncologia Medica, Policlinico di Modena, Modena

42016

Day Hospital Oncologico, Ospedale Guastalla, Guastalla

42123

Oncologia , IRCCS azienda ospedaliera S.Maria Nuova, Reggio Emilia

43100

Oncologia Medica AOU Parma, Parma

44124

Oncologia Medica AOU Ferrara, Ferrara

47014

IRST Oncologia medica, Meldola

47923

U.O Oncologia AUSLdella Romagna, Rimini

All Listed Sponsors
lead

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

NCT02488564 - A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter