We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193089
First Posted: September 19, 2005
Last Update Posted: December 10, 2015
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.
Collaborators:
Aventis Pharmaceuticals
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
September 12, 2005
September 19, 2005
December 10, 2015
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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. doi: 10.3816/CBC.2009.n.004.

*   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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00193089
SCRI BRE 46
GIA 11180
H2369n
Yes
Not Provided
Not Provided
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
  • Aventis Pharmaceuticals
  • GlaxoSmithKline
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
December 2015

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