A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.

Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes

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.

Inclusion Criteria:

• Female patients, 18-65 years of age
• Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
• Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
• ECOG performance status 0-2

Exclusion Criteria:

• CNS metastases which are not well controlled
• Simultaneous treatment with sorivudine
• History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
• Pregnant or lactating women