1st-line treatment of HER2/neu overexpressing breast cancer

The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.

Inclusion Criteria:

• Histologically proven, metastatic breats cancer.

• HER2-neu overexpression (IHC3+ or IHC2+/FISH+)

• Written informed consent

• no previous therapy with vinorelbine or trastuzumab

• Age * 18 and * 75 years

• Karnofsky-Performance status > 70%

• Life expectance 16 weeks and more

• Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions

• Exclusion of pregnancy and adequte contraception during childbearing age.

  • Adequate hematological, renal, and hepatic function

• Normal cardiac function. LVEF should not be >10% below normal.

• Adequate compliance to perform treatment and subsequent follow-up visits

Exclusion Criteria:

• Locoregional recurrence of breast cancer only or development of contralateral breast cancer
• Pregnancy or lactation
• Symptomatic brain- or meningeal metastasis
• Concurrent endocrine antitumor therapy
• Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
• Peripheral neuropathy >= NCI CTC Grade 2.
• other severel disease which preclude adequate treatment
• Participation in a clinical trial within the last 30 days.
• Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up