Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)

PHASE2CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

July 16, 2007

Primary Completion Date

August 23, 2010

Study Completion Date

August 23, 2010

Conditions
Breast Neoplasm
Interventions
DRUG

doxorubicin, cyclophosphamide, paclitaxel, trastuzumab

doxorubicin 60 mg/m\^2 IV push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)

DRUG

PLD, cyclophosphamide, trastuzumab, paclitaxel

PLD 35 mg/m\^2 IV over 60 minutes + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00550771 - Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048) | Biotech Hunter | Biotech Hunter