Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Imatinib; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193180

SCRI BRE 74

Details and patient eligibility

About

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.

Full description

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

37 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: Imatinib