NCT00193180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started May 2005

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2013

Completed
Last Updated

May 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

September 12, 2005

Results QC Date

March 25, 2013

Last Update Submit

April 27, 2016

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Progression Free Survival (PFS)

    18 months

  • Overall Survival (OS)

    18 months

Study Arms (1)

Intervention

EXPERIMENTAL

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: ImatinibDrug: Docetaxel

Interventions

ImatinibDRUG

Imatinib

Also known as: Gleevec
Intervention
DocetaxelDRUG

Docetaxel

Also known as: Taxotere
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70806, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Yardley DA, Burris HA 3rd, Markus T, Spigel DR, Greco FA, Mainwaring M, Waterhouse DM, Webb CD, Hainsworth JD. Phase II trial of docetaxal plus imatinib mesylate in the treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):237-42. doi: 10.3816/CBC.2009.n.040.

    PMID: 19933079RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Imatinib MesylateDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Results Point of Contact

Title
John D. Hainsworth, MD
Organization
Sarah Cannon Research Institute
ASKSARAH@scresearch.net
877-691-7274

Study Officials

  • Denise A. Yardley, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2008

Study Completion

January 1, 2009

Last Updated

May 27, 2016

Results First Posted

May 14, 2013

Record last verified: 2016-04

Locations

US(6)