Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
GlaxoSmithKline
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193089
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011

September 12, 2005
May 2, 2011
April 2001
April 2005   (final data collection date for primary outcome measure)
feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.
Complete list of historical versions of study NCT00193089 on ClinicalTrials.gov Archive Site
Not Provided
obtain preliminary efficacy data with this combination in the first-line treatment of metastatic breast cancer.
Not Provided
Not Provided
 
Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer
Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2

In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    Docetaxel
  • Drug: Vinorelbine
    Vinorelbine
  • Drug: Trastuzumab
    Trastuzumab
Not Provided
Infante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer. 2009 Feb;9(1):23-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2009
April 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Metastatic breast cancer confirmed by biopsy
  • Overexpression of the Her-2 oncogene
  • Age > 18 years
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • No previous chemotherapy for metastatic disease
  • One or more previous hormonal therapies for metastatic disease.
  • Adequate bone marrow, liver and kidney function
  • Patients with < grade 1 peripheral neuropathy are eligible.
  • Must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Abnormal heart function
  • Previous treatment with trastuzumab
  • Brain metastases untreated
  • Pre-existing symptomatic peripheral neuropathy
  • Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193089
SCRI BRE 46, GIA 11180, H2369n
Not Provided
Denise A. Yardley, M.D., Sarah Cannon Research Institute
SCRI Development Innovations, LLC
  • Aventis Pharmaceuticals
  • GlaxoSmithKline
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP