A Phase 2 interventional study of SKI-606 (Bosutinib) in Breast Neoplasms and Neoplasm Metastasis, sponsored by Pfizer. Completed at 15 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SKI-606 (Bosutinib)
SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
Progression-Free Survival (PFS) Rate
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.
Time frame: Baseline up to Week 16
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Baseline up to 30 days after last dose of study treatment
Overall Survival (OS)
OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.
Time frame: Baseline up to Year 2
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (\>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response.
Time frame: Baseline up to Year 1
Percentage of Participants With Clinical Benefit
Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (\>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD \>24 weeks at any time while on study was counted in the numerator.
Time frame: Baseline up to end of treatment (Week 77)
Number of Participants With Change From Baseline in Laboratory Test Results
Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>5\*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin \>3\*ULN micromole/L; sodium \<130, magnesium \<0.4 and \>1.23 millimole/L; lipase \>2\*ULN microkats/L; neutrophils \<1\*10\^9/L. Participants meeting at least 1 PCS criteria are reported.
Time frame: Baseline up to end of treatment (Week 77)
Number of Participants With Change From Baseline in Electrocardiogram (ECG)
Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate \>=120 beats per minute (bpm) or increase \>=15 bpm; QT interval corrected using Bazett's formula (QTcB) \>60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.
Time frame: Baseline up to end of treatment (Week 77)
Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations
Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate \>25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of \>=7% in body weight.
Time frame: Baseline up to end of treatment (Week 77)
Concomitant Medications Used for Management of Adverse Events (AEs)
Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.
Time frame: Day 1 up to end of treatment (Week 77)
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
KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.
Time frame: Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment
Population Pharmacokinetics (PK)
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time frame: Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24
| Milestone | Bosutinib |
|---|---|
| Started | 75 |
| Treated | 73 |
| Completed | 21 |
| Not completed | 54 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Death | 46 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Enrolled, not treated | 2 |
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.
| percentage of participants | Bosutinib |
|---|---|
| Progression-Free Survival (PFS) Rate | 39.6 (28.1 to 50.8) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
| percentage of participants | Bosutinib |
|---|---|
| AEs | 97 |
| SAEs | 33 |
OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.
| percentage of participants | Bosutinib |
|---|---|
| Overall Survival (OS) | 26.4 (14.7 to 39.7) |
Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (\>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response.
| percentage of participants | Bosutinib |
|---|---|
| Percentage of Participants With Objective Response (OR) | 5.5 (1.5 to 13.4) |
Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (\>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD \>24 weeks at any time while on study was counted in the numerator.
| percentage of participants | Bosutinib |
|---|---|
| Percentage of Participants With Clinical Benefit | 27.4 (17.6 to 39.1) |
Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>5\*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin \>3\*ULN micromole/L; sodium \<130, magnesium \<0.4 and \>1.23 millimole/L; lipase \>2\*ULN microkats/L; neutrophils \<1\*10\^9/L. Participants meeting at least 1 PCS criteria are reported.
| participants | Bosutinib |
|---|---|
| Sodium (<130 mmol/L) | 2 |
| Magnesium (<0.4 mmol/L) | 3 |
| Magnesium (>1.23 mmol/L) | 3 |
| Total Bilirubin (>3*ULN) | 1 |
| ALT (>5*ULN) | 12 |
| AST (>5*ULN) | 10 |
| Lipase (>2*ULN) | 1 |
| Neutrophils (<1*10^9/L) | 1 |
Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate \>=120 beats per minute (bpm) or increase \>=15 bpm; QT interval corrected using Bazett's formula (QTcB) \>60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.
| participants | Bosutinib |
|---|---|
| No sinus rhythm | 12 |
| Heart Rate (>=120 bpm and increase >=15bpm) | 2 |
| QTcB Interval (>60 msec change from baseline) | 1 |
| Overall ECG not normal | 12 |
Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate \>25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of \>=7% in body weight.
| participants | Bosutinib |
|---|---|
| Respiratory Rate (> 25 breaths/minute) | 6 |
| Weight (decrease >=7%) | 9 |
| Weight (increase >=7%) | 1 |
| Ophthalmological examinations | 0 |
Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.
No measurements were reported for this outcome.
KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.
No measurements were reported for this outcome.
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bosutinib | — | 24/73 (32.9%) | 70/73 (95.9%) |
| Event | Bosutinib |
|---|---|
| Alanine aminotransferase increasedInvestigations | 3/73 |
| DiarrhoeaGastrointestinal disorders | 2/73 |
| Disease progressionGeneral disorders | 2/73 |
| Oedema peripheralGeneral disorders | 2/73 |
| Aspartate aminotransferase increasedInvestigations | 2/73 |
| Breast painReproductive system and breast disorders | 2/73 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/73 |
| IleusGastrointestinal disorders | 1/73 |
| VomitingGastrointestinal disorders | 1/73 |
| Chest discomfortGeneral disorders | 1/73 |
| Event | Bosutinib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 48/73 |
| NauseaGastrointestinal disorders | 40/73 |
| VomitingGastrointestinal disorders | 33/73 |
| FatigueGeneral disorders | 19/73 |
| AstheniaGeneral disorders | 14/73 |
| AnorexiaMetabolism and nutrition disorders | 14/73 |
| HeadacheNervous system disorders | 10/73 |
| RashSkin and subcutaneous tissue disorders | 10/73 |
| Abdominal painGastrointestinal disorders | 9/73 |
| Alanine aminotransferase increasedInvestigations | 9/73 |
| Age Continuous(years) | Bosutinib |
|---|---|
| Mean | 54.27 ± 9.81 |
| Sex: Female, Male(Participants) | Bosutinib |
|---|---|
| Female | 73 |
| Male | 0 |
The record gives a start of May 2006, a primary completion of Feb 2009 and a completion of Feb 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2013, 3 years 11 months after primary completion. A results delay was requested in Jan 2010.
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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bosutinib