Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Study Overview
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Brief Summary
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This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

Detailed Description
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All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Official Title
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Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Imatinib
* Drug: Docetaxel


Participation Criteria
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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 No more than one prior chemotherapy regimen for metastatic breast cancer Able to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function Age 18 years or older Give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Moderate to severe peripheral neuropathy Uncontrolled blood pressure or uncontrolled heart beat irregularities Diabetes Mellitus with fasting blood sugar greater than 200 mg % Significant heart disease within the prior 6 months Severe or uncontrolled medical disease Active uncontrolled infection Known chronic liver disease Known diagnosis of HIV infection Pregnant or breast feeding females 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. | Drug: Imatinib<br>* Imatinib<br>* Other names: Gleevec;Drug: Docetaxel<br>* Docetaxel<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | 18 months | 
| Overall Survival (OS) | Defined as the time from first protocol treatment to date of death due to any cause. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer