NCT00546104

Brief Summary

The purpose of this study is to find out if dasatinib will safely reduce the size or spread of your tumor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
1 country

3 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

October 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 17, 2013

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

3.6 years

First QC Date

October 16, 2007

Results QC Date

January 22, 2013

Last Update Submit

July 15, 2013

Conditions

Advanced Breast Cancer

Keywords

Advanced Breast CancerBreast cancerDasatinibInoperable Stage III Breast CancerMetastatic Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Estimation of the Proportion of Progression-free Patients at 16 Wks.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate. Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first.

    16 weeks

Secondary Outcomes (5)

  • To Measure Response to Protocol Therapy Per RECIST Criteria

    16 weeks

  • Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response)

    4 weeks

  • Correlate SRC Dysregulation Results With Response to Dasatinib Therapy

    16 weeks

  • To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression.

    Baseline Src measure to first progression

  • To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption

    not assessed

Study Arms (1)

Dasatinib

EXPERIMENTAL

50- 100 mg PO BID

Drug: Dasatinib

Interventions

DasatinibDRUG

An initial dose of 50 mg PO BID; following 4 weeks of treatment, dose adjustment will be based on inhibition of phosphorylation of FAK and paxillin per biopsy assessment, as well as toxicity assessment.

Also known as: Sprycel, BMS-354825
Dasatinib

Eligibility Criteria

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

You may qualify if:

  • Measurable Stage IV or inoperable Stage III advanced breast cancer.
  • There is no limit on the number of prior therapies.
  • At least 3 weeks since prior chemotherapy, biological or hormonal therapy.
  • At least 2 weeks since surgical biopsy.
  • At least 3 weeks since major (open thoracic/abdominal/cardiac) surgery.
  • No central nervous system (CNS) metastases except solitary brain metastasis
  • No cardiac dysfunction
  • left ventricular ejection fraction (LVEF) ≥ 50% as determined by multiple gated acquisition scan (MUGA)/echocardiogram
  • Adequate blood counts
  • Normal liver and kidney function
  • Negative serum pregnancy test.
  • Able to provide informed consent

You may not qualify if:

  • Pregnant or breast feeding.
  • Prior treatment with dasatinib.
  • Bone as the only site of disease.
  • Significant gastrointestinal bleeding
  • Septicemia, infection, acute hepatitis, hypokalemia, or hypomagnesemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Palm Beach Cancer Center Institute

West Palm Beach, Florida, 33401, United States

Location

Presbyterian Health Care

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Kimberly Blackwell, MD
Organization
Duke University Health System
kimberly.blackwell@duke.edu
919-668-1478

Study Officials

  • Kimberly Blackwell, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 18, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 17, 2013

Results First Posted

July 17, 2013

Record last verified: 2013-07

Locations

US(3)