Phase 2 Completed N=31 Treatment

Phase II Dasatinib Study in Advanced Breast Cancer

Source: ClinicalTrials.gov NCT00546104 ↗

Enrolled (actual)

Serious AEs

32.3%

Results posted

Jul 2013

Primary outcomePrimary: Estimation of the Proportion of Progression-free Patients at 16 Wks. — 0 percentage of participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Estimation of the Proportion of Progression-free Patients at 16 Wks.	—	—
SECONDARY To Measure Response to Protocol Therapy Per RECIST Criteria	16.7	—
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)	-0.125	0.3
SECONDARY Correlate SRC Dysregulation Results With Response to Dasatinib Therapy	-.10	0.3
SECONDARY To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression.	0.27	—
SECONDARY To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00546104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.