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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

1st-line treatment of HER2/neu overexpressing breast cancer

• Phase: Phase 2

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: Pierre Fabre Laboratories
• Treatments: Trastuzumab; Vinblastine; Vinorelbine

Criteria

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