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

NCT ID: NCT00193089

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2009-09-30

Brief Summary

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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

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Upon determination of eligibility, all patients will be receive:

Trastuzumab + Vinorelbine + Docetaxel

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Docetaxel

Intervention Type DRUG

Vinorelbine

Vinorelbine

Intervention Type DRUG

Trastuzumab

Trastuzumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aventis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

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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.

Reference Type RESULT
PMID: 19299236 (View on PubMed)

Other Identifiers

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GIA 11180

Identifier Type: -

Identifier Source: secondary_id

H2369n

Identifier Type: -

Identifier Source: secondary_id

SCRI BRE 46

Identifier Type: -

Identifier Source: org_study_id