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

Phase 2CompletedNCT00193089

SCRI Development Innovations, LLC60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

DocetaxelDRUG

Docetaxel

VinorelbineDRUG

Vinorelbine

TrastuzumabDRUG

Trastuzumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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