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

This study has been completed.
Pierre Fabre Laboratories
Information provided by:
Ludwig-Maximilians - University of Munich Identifier:
First received: February 7, 2007
Last updated: March 11, 2011
Last verified: February 2007
1st-line treatment of HER2/neu overexpressing breast cancer

Condition Intervention Phase
Carcinoma Breast Stage IV
Drug: Navelbine
Drug: Herceptin
Drug: Navelbine (oraly)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Time to tumor progression
  • Overall survival
  • Safety

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
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Please refer to this study by its identifier: NCT00433095

University of Munich - Klinikum Grosshdern
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Pierre Fabre Laboratories
Principal Investigator: Volker Heinemann, PhD, MD University of Munich - Klinikum Grosshadern
Study Chair: Hans-Joachim Stemmler, PhD, MD University of Munich - Klinikum Grosshadern
  More Information

No publications provided Identifier: NCT00433095     History of Changes
Other Study ID Numbers: Mamma-2-2004
Study First Received: February 7, 2007
Last Updated: March 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Therapeutic Uses processed this record on December 01, 2015