Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-01-31

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.

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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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

Imatinib

Docetaxel

Intervention Type DRUG

Docetaxel

Interventions

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Imatinib

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Other Intervention Names

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Gleevec Taxotere

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No