Conditions: Breast Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: capecitabine [Xeloda] intervention 2: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: 900mg/m2 bid po on days 1-14 of each 3-week cycle intervention 2: 8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks

Protocol document: