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
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Vinorelbine
Drug: Trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2001
Study Completion Date: September 2009
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    Docetaxel
    Drug: Vinorelbine
    Vinorelbine
    Drug: Trastuzumab
    Trastuzumab
Detailed Description:

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT00193089

Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
GlaxoSmithKline
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193089     History of Changes
Other Study ID Numbers: SCRI BRE 46, GIA 11180, H2369n
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Docetaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014