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

March 11, 2011 updated by: Ludwig-Maximilians - University of Munich
1st-line treatment of HER2/neu overexpressing breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • University of Munich - Klinikum Grosshdern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Overall survival
Safety
Time to tumor progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 7, 2007

First Submitted That Met QC Criteria

February 7, 2007

First Posted (Estimate)

February 9, 2007

Study Record Updates

Last Update Posted (Estimate)

March 14, 2011

Last Update Submitted That Met QC Criteria

March 11, 2011

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mamma-2-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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