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:

Sarah Cannon Research Institute

ClinicalTrials.gov Identifier:

NCT00193089

First received: September 12, 2005

Last updated: May 2, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

May 2, 2011

Start Date ^ICMJE

April 2001

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.

Change History

Complete list of historical versions of study NCT00193089 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

obtain preliminary efficacy data with this combination in the first-line treatment of metastatic breast cancer.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Docetaxel
Docetaxel
Drug: Vinorelbine
Vinorelbine
Drug: Trastuzumab
Trastuzumab

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00193089

Other Study ID Numbers ^ICMJE

SCRI BRE 46, GIA 11180, H2369n

Has Data Monitoring Committee

Not Provided

Responsible Party

Denise A. Yardley, M.D., Sarah Cannon Research Institute

Study Sponsor ^ICMJE

Sarah Cannon Research Institute

Collaborators ^ICMJE

Aventis Pharmaceuticals
GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

Information Provided By

Sarah Cannon Research Institute

Verification Date

May 2011

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

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