Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
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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.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
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
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