Clinical trial · Interventional
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer
NCT00371345CI-TRIAL-00004727completedPhase 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)
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib
- description
- Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).
- interventionNames
- Drug: Dasatinib
- Drug: Dasatinib 100 mg
Primary outcomes (3)
- measure
- Number of Participants With Objective Response
- timeFrame
- From day of first treatment through Week 25 or at time of discontinuation from study treatment.
- description
- Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.
- measure
- Percentage of Participants With Objective Response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * females, 18 or older * recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu * paraffin-embedded tissue block must be available * measurable disease * prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting) * 0, 1 or 2 chemotherapies in the metastatic setting * adequate organ function Exclusion Criteria: * Metastatic disease confined to bone only * Symptomatic central nervous system (CNS) metastasis * Concurrent medical condition which may increase the risk of toxicity * Unable to take oral medication
References
Publications (0)
Data not yet available
No reference posted for this study.