Clinical trial · Interventional
Phase II Dasatinib Study in Advanced Breast Cancer
A Phase II Trial of Dasatinib to Treat Women With Stage IV or Inoperable Stage III Advanced Breast Cancer
NCT00546104CI-TRIAL-00011386completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out if dasatinib will safely reduce the size or spread of your tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib
- description
- 50- 100 mg PO BID
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- Estimation of the Proportion of Progression-free Patients at 16 Wks.
- timeFrame
- 16 weeks
- description
- 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.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.