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

Ludwig Maximilian University of Munich

Status and phase

Completed

Phase 2

Conditions

Carcinoma Breast Stage IV

Treatments

Drug: Navelbine

Drug: Herceptin

Drug: Navelbine (oraly)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00433095

Mamma-2-2004

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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