T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Breast Cancer
Interventions
DRUG

Trastuzumab and non-pegylated liposomal doxorubicin

"3 Cohorts (3+3 design):~Cohort 1- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2) IV~Cohort 2- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (50 mg/m2) IV~Cohort 3- Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (60 mg/m2) IV"

Trial Locations (4)

75020

MedSIR investigative site, Paris

92210

MedSIR investigative site, Paris

00835

MedSIR investigative site, Barcelona

08035

MedSIR investigative site, Madrid

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

collaborator

Experior

INDUSTRY

lead

MedSIR

OTHER

NCT02562378 - T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter