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

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT00433095

Collaborator

Pierre Fabre Laboratories (Industry)

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Breast Stage IV	Drug: Navelbine Drug: Herceptin Drug: Navelbine (oraly)	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Outcome Measures

Primary Outcome Measures

Response rate []

Secondary Outcome Measures

Time to tumor progression []
Overall survival []
Safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Munich - Klinikum Grosshdern	Munich		Germany	81377

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich
Pierre Fabre Laboratories

Investigators

Principal Investigator: Volker Heinemann, PhD, MD, University of Munich - Klinikum Grosshadern
Study Chair: Hans-Joachim Stemmler, PhD, MD, University of Munich - Klinikum Grosshadern