Phase 2
Completed N=75
Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Breast Neoplasms · Neoplasm Metastasis
Source: ClinicalTrials.gov NCT00319254 ↗
Enrolled (actual)
75
Serious AEs
32.9%
Results posted
Jan 2013
Primary outcomePrimary: Progression-Free Survival (PFS) Rate — 39.6 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) Rate |
39.6 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) |
97; 33 | — |
| SECONDARY Overall Survival (OS) |
26.4 | — |
| SECONDARY Percentage of Participants With Objective Response (OR) |
5.5 | — |
| SECONDARY Percentage of Participants With Clinical Benefit |
27.4 | — |
| SECONDARY Number of Participants With Change From Baseline in Laboratory Test Results |
2; 3; 3; 1; 12; 10 | — |
| SECONDARY Number of Participants With Change From Baseline in Electrocardiogram (ECG) |
12; 2; 1; 12 | — |
| SECONDARY Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations |
6; 9; 1; 0 | — |
| SECONDARY Concomitant Medications Used for Management of Adverse Events (AEs) |
— | — |
| SECONDARY Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00319254). 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.