A Phase 2 interventional study of SU011248/Trastuzumab in Breast Neoplasms, sponsored by Pfizer. Completed at 27 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Drug: SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
Percentage of Participants With Overall Confirmed Objective Disease Response
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
Time frame: From start of treatment through 18 months
Duration of Response (DR)
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.
Time frame: From start of treatment through 18 months
Percentage of Participants With Clinical Benefit
Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as \>=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.
Time frame: From start of treatment through 18 months
Progression Free Survival (PFS)
Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.
Time frame: From start of treatment through 18 months
Time to Progression (TTP)
Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.
Time frame: From start of treatment through 18 months
Overall Survival (OS)
Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 \* 4.33.
Time frame: From start of study treatment until death or 2 years from first study treatment
Probability of Survival at One Year
One- year survival probability was estimated using the Kaplan-Meier method.
Time frame: From start of study treatment until death or 2 years from first study treatment
EORTC QLQ-C30
EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
Time frame: From start of treatment through 18 months
EORTC QLQ (BR23)
BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Time frame: From start of treatment through 18 months
Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Time frame: Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Time frame: Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Time frame: Predose on Day 1 of Cycle 3 and 5
| Milestone | Trastuzumab + Sunitinib |
|---|---|
| Started | 60 |
| Completed | 2 |
| Not completed | 58 |
| Withdrew: Adverse event | 11 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lack of efficacy | 44 |
| Withdrew: Death | 1 |
| Withdrew: Other | 1 |
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
| percentage of participants | Trastuzumab + Sunitinib |
|---|---|
| Percentage of Participants With Overall Confirmed Objective Disease Response | 36.8 (24.4 to 50.7) |
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.
| weeks | Trastuzumab + Sunitinib |
|---|---|
| Duration of Response (DR) | 25.6 (22.4 to 32.9) |
Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as \>=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.
| Percentage of Participants | Trastuzumab + Sunitinib |
|---|---|
| Percentage of Participants With Clinical Benefit | 56.1 (42.4 to 69.3) |
Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.
| Weeks | Trastuzumab + Sunitinib |
|---|---|
| Progression Free Survival (PFS) | 28.0 (24.1 to 31.3) |
Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.
| weeks | Trastuzumab + Sunitinib |
|---|---|
| Time to Progression (TTP) | 26.0 (23.3 to 31.1) |
Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 \* 4.33.
| months | Trastuzumab + Sunitinib |
|---|---|
| Overall Survival (OS) | NA (NA to NA) |
One- year survival probability was estimated using the Kaplan-Meier method.
| percentage of 1-year survival | Trastuzumab + Sunitinib |
|---|---|
| Probability of Survival at One Year | 91.2 (80.2 to 96.3) |
EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
| scores on a scale | Trastuzumab + Sunitinib |
|---|---|
| Function Score: Global health (n=28) | 56.0 ± 21.4 |
| Function Score: Physical function (n=28) | 75.2 ± 16.8 |
| Function Score: Role function (n=28) | 60.1 ± 28.8 |
| Function Score: Cognitive function (n=28) | 84.5 ± 21.7 |
| Function Score: Emotional function (n=28) | 66.1 ± 27.5 |
| Function Score: Social function (n=28) | 66.7 ± 28.3 |
| Symptom Score: Fatigue (n=28) | 45.0 ± 25.3 |
| Symptom Score: Pain (n=28) | 36.9 ± 25.8 |
| Symptom Score: Nausea/vomiting (n=28) | 6.5 ± 10.5 |
| Symptom Score: Dyspnea (n=28) | 26.2 ± 30.6 |
| Symptom Score: Loss of appetite (n=28) | 20.2 ± 24.6 |
| Symptom Score: Insomnia (n=28) | 29.8 ± 27.7 |
| Symptom Score: Constipation (n=27) | 14.8 ± 26.7 |
| Symptom Score: Diarrhea (n=27) | 32.1 ± 32.7 |
| Symptom Score: Financial difficulty (n=28) | 17.9 ± 29.4 |
BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
| scores on a scale | Trastuzumab + Sunitinib |
|---|---|
| Function Score : Body image (n=27) | 76.4 ± 29.5 |
| Function Score: Sexual function (n=24) | 14.6 ± 16.5 |
| Function Score: Sexual enjoyment (n=10) | 33.3 ± 15.7 |
| Others :Future health perspective (n=27) | 45.7 ± 34.8 |
| Symptom Score: systemic therapy side effects(n=27) | 21.7 ± 15.8 |
| Symptom Score: Breast (n=27) | 19.4 ± 23.6 |
| Symptom Score: Arm (n=27) | 21.0 ± 23.9 |
| Others :Upset of hair loss (n=6) | 44.4 ± 27.2 |
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
| nanograms (ng)/milliliter (mL) | Trastuzumab + Sunitinib |
|---|---|
| Day 1 (Cycle 3) | 53.5 ± 27.6 |
| Day 1 (Cycle 5) | 55.0 ± 24.8 |
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
| ng/mL | Trastuzumab + Sunitinib |
|---|---|
| Day 1 (Cycle 3) | 26.7 ± 14.4 |
| Day 1 (Cycle 5) | 24.7 ± 12.5 |
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
| ng/mL | Trastuzumab + Sunitinib |
|---|---|
| Day 1 (Cycle 3) | 80.2 ± 39.9 |
| Day 1 (Cycle 5) | 79.7 ± 36.3 |
Collected over From time of informed consent signing (SAEs) or first study treatment (AEs) through 18 months and including 28 calendar days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab + Sunitinib | — | 25/60 (41.7%) | 59/60 (98.3%) |
| Event | Trastuzumab + Sunitinib |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 3/60 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/60 |
| PancreatitisGastrointestinal disorders | 2/60 |
| VomitingGastrointestinal disorders | 2/60 |
| AstheniaGeneral disorders | 2/60 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 2/60 |
| HypertensionVascular disorders | 2/60 |
| AnaemiaBlood and lymphatic system disorders | 1/60 |
| Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders | 1/60 |
| Cardiac failureCardiac disorders | 1/60 |
| Event | Trastuzumab + Sunitinib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 36/60 |
| AstheniaGeneral disorders | 29/60 |
| DysgeusiaNervous system disorders | 27/60 |
| HypertensionVascular disorders | 25/60 |
| VomitingGastrointestinal disorders | 21/60 |
| Mucosal inflammationGeneral disorders | 21/60 |
| DyspepsiaGastrointestinal disorders | 20/60 |
| NauseaGastrointestinal disorders | 20/60 |
| FatigueGeneral disorders | 19/60 |
| HeadacheNervous system disorders | 18/60 |
| Age Continuous(Years) | Trastuzumab + Sunitinib |
|---|---|
| Mean | 55.1 ± 12.8 |
| Sex: Female, Male(Participants) | Trastuzumab + Sunitinib |
|---|---|
| Female | 60 |
| Male | 0 |
| EORTC QLQ-C30(scores on a scale) | Trastuzumab + Sunitinib |
|---|---|
| Function Score: Global health (n=48) | 66.8 ± 26.8 |
| Function Score: Physical function (n=49) | 79.5 ± 21.3 |
| Function Score: Role function (n=49) | 76.2 ± 30.0 |
| Function Score: Cognitive function (n=49) | 82.0 ± 25.6 |
| Function Score: Emotional function (n=49) | 62.8 ± 26.4 |
| Function Score: Social function (n=49) | 75.5 ± 29.9 |
| Symptom Score: Fatigue (n=49) | 35.6 ± 27.6 |
| Symptom Score: Pain (n=49) | 38.8 ± 33.7 |
| Symptom Score: Nausea/vomiting (n=49) | 7.1 ± 18.0 |
| Symptom Score: Dyspnea (n=48) | 22.9 ± 28.5 |
| Symptom Score: Loss of appetite (n=49) | 14.3 ± 28.1 |
| Symptom Score: Insomnia (n=49) | 35.4 ± 31.5 |
| Symptom Score: Constipation (n=48) | 18.1 ± 32.9 |
| Symptom Score: Diarrhea (n=49) | 6.8 ± 15.2 |
| Symptom Score: Financial difficulty (n=48) | 15.3 ± 28.3 |
| EORTC QLQ Breast Cancer Module (BR23)(scores on a scale) | Trastuzumab + Sunitinib |
|---|---|
| Function Score : Body image (n=46) | 77.2 ± 25.4 |
| Function Score: Sexual function (n=44) | 21.6 ± 24.5 |
| Function Score: Sexual enjoyment (n=15) | 53.3 ± 21.1 |
| Symptom Score: Arm (n=48) | 23.8 ± 25.3 |
| Symptom Score: Breast (n=47) | 25.9 ± 27.5 |
| Symptom Score: systemic therapy side effects(n=48) | 17.2 ± 17.4 |
| Others :Upset of hair loss (n=6) | 50.0 ± 27.9 |
| Others :Future health perspective (n=48) | 39.6 ± 32.0 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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