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

NCT ID: NCT00433095

Last Updated: 2011-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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 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.

Conditions

Carcinoma Breast Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Navelbine

Intervention Type: DRUG

Herceptin

Intervention Type: DRUG

Navelbine (oraly)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Laboratories

INDUSTRY

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Principal Investigators

Volker Heinemann, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Munich - Klinikum Grosshadern

Hans-Joachim Stemmler, PhD, MD

Role: STUDY_CHAIR

University of Munich - Klinikum Grosshadern

Locations

University of Munich - Klinikum Grosshdern

Munich, , Germany

Countries

Germany

Other Identifiers

Mamma-2-2004

Identifier Type: -

Identifier Source: org_study_id