Carcinoma Breast Stage IV
Conditions
Keywords
Navelbine, Herceptin, oral, breast cancer
Brief summary
1st-line treatment of HER2/neu overexpressing breast cancer
Detailed description
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.
Interventions
Sponsors
Pierre Fabre Laboratories
Ludwig-Maximilians - University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to tumor progression | — |
| Overall survival | — |
| Safety | — |
Countries
Germany
Outcome results
None listed