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

This study has been completed.
Sponsor:
Collaborator:
Pierre Fabre Laboratories
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00433095
First received: February 7, 2007
Last updated: March 11, 2011
Last verified: February 2007
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433095

Locations
Germany
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
  More Information

No publications provided

ClinicalTrials.gov 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:
Navelbine
Herceptin
oral
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vinorelbine
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014