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.

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Trastuzumab

Criteria

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