Advanced Breast Cancer Clinical Trial
Official title:
A Phase II Trial of Dasatinib to Treat Women With Stage IV or Inoperable Stage III Advanced Breast Cancer
Verified date | July 2013 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to find out if dasatinib will safely reduce the size or spread of your tumor.
Status | Completed |
Enrollment | 31 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Presbyterian Health Care | Charlotte | North Carolina |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Palm Beach Cancer Center Institute | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Duke University | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | To Measure Response to Protocol Therapy Per RECIST Criteria | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as a reference the smallest sum longest diameter recorded since treatment started, or the appearance of one or more new lesions. RECIST 1.0 Overall response: Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) CR= CR+CR and No new lesions PR= CR+SD; PR+SD and no new lesions SD= SD+SD and no new lesions PD= PD+any new lesions |
16 weeks | No |
Secondary | 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) | For the 20 patients with evaluable biopsies at baseline and week 4, the median relative change from baseline in tissue biomarker levels of phospho-Src (p-Src) | 4 weeks | No |
Secondary | Correlate SRC Dysregulation Results With Response to Dasatinib Therapy | Since all patients progressed there is no comparison to between responders and non-responders. | 16 weeks | No |
Secondary | To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression. | Spearman's correlation between the change in SRC signature from baseline to 4 weeks and time to progression | Baseline Src measure to first progression | No |
Secondary | To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption | Not assessed secondary to limited number of subjects. | not assessed | No |
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