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

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00193089
• Lead Sponsor: SCRI Development Innovations, LLC

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 Timeline

• Study Start: 2001-04
• Primary Completion: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2009-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.	18 Months