Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Imatinib; Drug: Docetaxel

• Registration Number: NCT00193180
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

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

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

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-05
• Study Completion: 2009-01
• Results First Submitted: 2013-03-25
• Results First Submitted QC: 2013-03-25
• Results First Posted: 2013-05-14
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Imatinib	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.
Intervention	Docetaxel	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	18 months	Defined as the time from first protocol treatment to date of death due to any cause.
Progression Free Survival (PFS)	18 months	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.

Trial Locations

Locations (6)

Baton Rouge General Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Methodist Cancer Center; 🇺🇸 Omaha, Nebraska, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Northeast Georgia Medical Center; 🇺🇸 Gainesville, Georgia, United States

Consultants in Blood Disorders and Cancer; 🇺🇸 Louisville, Kentucky, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States