18 Years
75 Years
Female
Carcinoma Breast Stage IV
Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Principal Investigator
Volker Heinemann, PhD, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Munich - Klinikum Grosshadern
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
Mamma-2-2004
NCT ID:
NCT00433095
Start Date:
Completion Date:
Related Keywords:
- Carcinoma Breast Stage IV
- Navelbine
- Herceptin
- oral
- breast cancer
- Breast Neoplasms
- Carcinoma
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