Status:
COMPLETED
Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Pierre Fabre Laboratories
Conditions:
Carcinoma Breast Stage IV
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 tolera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00433095
Last Update
March 14 2011
Active Locations (1)
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1
University of Munich - Klinikum Grosshdern
Munich, Germany, 81377