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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433095
Recruitment Status : Completed
First Posted : February 9, 2007
Last Update Posted : March 14, 2011
Pierre Fabre Laboratories
Information provided by:
Ludwig-Maximilians - University of Munich

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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Time to tumor progression
  2. Overall survival
  3. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00433095     History of Changes
Other Study ID Numbers: Mamma-2-2004
First Posted: February 9, 2007    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: February 2007

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action