Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer

Study Overview
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Brief Summary
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1st-line treatment of HER2/neu overexpressing breast cancer

Detailed Description
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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.

Conditions
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Carcinoma Breast Stage IV

Intervention / Treatment
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* Drug: Navelbine
* Drug: Herceptin
* Drug: Navelbine (oraly)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Navelbine|nan|
|Drug: Herceptin|nan|
|Drug: Navelbine (oraly)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor progression |  |  | 
| Overall survival |  |  | 
| Safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Navelbine, Herceptin, oral, breast cancer