Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: no

Brief summary:
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously \[iv\], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms:
arm 1: Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m\^2), every 3 weeks or paclitaxel 90 mg/m\^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.

Interventions: intervention 1: Docetaxel intervention 2: Paclitaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: 100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks) intervention 2: 90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks) intervention 3: 4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter

Protocol document: