NCT00687440 - A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 15, 2005

Primary Completion Date

October 24, 2008

Study Completion Date

October 24, 2008

Conditions

Breast Neoplasm

Interventions

DRUG

Pegylated Liposomal Doxorubicin

"Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m\^2 on day 1, every 3 weeks~Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks."

DRUG

Docetaxel

Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks.

DRUG

Trastuzumab

Stage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks).