Clinical trial · Interventional
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
NCT00319254CI-TRIAL-00009222completedPhase 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 determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SKI-606 (Bosutinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Advanced breast cancer
- interventionNames
- Drug: SKI-606 (Bosutinib)
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) Rate
- timeFrame
- Baseline up to Week 16
- description
- PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.
- measure
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to 30 days after last dose of study treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB, IIIC or IV breast cancer not curable with available therapy. * Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens. * Life expectancy of at least 16 weeks. * Ability to swallow whole capsules. Exclusion Criteria: * Use of or requirement for bisphosphonates within 8 weeks prior to screening. * Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ * Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc. * Recent or ongoing significant gastrointestinal disorder
References
Publications (0)
Data not yet available
No reference posted for this study.