A Phase 3 interventional study of Capecitabine and Sunitinib malate in Breast Neoplasms, sponsored by Pfizer. Terminated at 123 sites in 23 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-25.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated
Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 482 is above 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Drug: Capecitabine
37.5 mg daily, continuous dosing
Drug: Sunitinib malate
1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Also known as: xeloda
37.5 mg daily, continuous dosing
Also known as: sunitinib
Progression-Free Survival (PFS)
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
Time frame: From time of randomization to every 6 weeks thereafter through 22 months or until death
Time to Tumor Progression (TTP)
Time from randomization to first documentation of objective tumor progression.
Time frame: From time of randomization to every 6 weeks thereafter through 22 months
Number of Participants With Overall Response (OR)
OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (\>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: From time of randomization to every 6 weeks thereafter through 22 months
Duration of Response (DR)
Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a \>= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Time frame: From time of randomization to every 6 weeks thereafter through 22 months or death
Time to Tumor Response (TTR)
Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a \>= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Time frame: From time of randomization to every 6 weeks thereafter through 22 months
Overall Survival (OS)
Average time from randomization to first documentation of death due to any cause.
Time frame: From time of randomization until death
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 scales: 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 Day 1 of Cycle 1, then odd numbered cycles thereafter
EORTC QLQ Breast Cancer Module (BR23)
BR23: 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 implied a greater degree of symptoms.
Time frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter
| Milestone | Sunitinib | Capecitabine |
|---|---|---|
| Started | 238 | 244 |
| Received treatment | 238 | 240 |
| Completed | 0 | 0 |
| Not completed | 238 | 244 |
| Withdrew: Death | 1 | 7 |
| Withdrew: Adverse event | 38 | 24 |
| Withdrew: Study terminated by sponsor | 9 | 1 |
| Withdrew: Global deterioration of health status | 10 | 7 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Objective progression or relapse | 150 | 169 |
| Withdrew: Other | 14 | 17 |
| Withdrew: Protocol violation | 5 | 1 |
| Withdrew: Withdrawal by subject | 10 | 15 |
Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
| Months | Sunitinib | Capecitabine |
|---|---|---|
| Progression-Free Survival (PFS) | 2.8 (2.4 to 4.0) | 4.2 (3.8 to 5.5) |
Time from randomization to first documentation of objective tumor progression.
| Months | Sunitinib | Capecitabine |
|---|---|---|
| Time to Tumor Progression (TTP) | 2.8 (2.5 to 4.0) | 4.2 (3.8 to 5.5) |
OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (\>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
| Participants | Sunitinib | Capecitabine |
|---|---|---|
| Number of Participants With Overall Response (OR) | 27 | 40 |
Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a \>= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
| Months | Sunitinib | Capecitabine |
|---|---|---|
| Duration of Response (DR) | 6.9 (3.1 to 8.5) | 9.3 (5.5 to 9.7) |
Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a \>= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
No measurements were reported for this outcome.
Average time from randomization to first documentation of death due to any cause.
| Months | Sunitinib | Capecitabine |
|---|---|---|
| Overall Survival (OS) | 15.3 (12.0 to 24.7) | 16.9 (14.5 to 26.0) |
EORTC QLQ-C30 scales: 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.
No measurements were reported for this outcome.
BR23: 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 implied a greater degree of symptoms.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | — | 72/238 (30.3%) | 228/238 (95.8%) |
| Capecitabine | — | 44/240 (18.3%) | 229/240 (95.4%) |
| Event | Sunitinib | Capecitabine |
|---|---|---|
| Disease progressionGeneral disorders | 14/238 | 8/240 |
| DiarrhoeaGastrointestinal disorders | 3/238 | 7/240 |
| PneumoniaInfections and infestations | 5/238 | 0/240 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/238 | 1/240 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/238 | 5/240 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/238 | 5/240 |
| Cardiac failureCardiac disorders | 3/238 | 0/240 |
| AscitesGastrointestinal disorders | 3/238 | 0/240 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 3/238 | 0/240 |
| VomitingGastrointestinal disorders | 3/238 | 2/240 |
| Event | Sunitinib | Capecitabine |
|---|---|---|
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 80/238 | 149/240 |
| DiarrhoeaGastrointestinal disorders | 97/238 | 95/240 |
| NauseaGastrointestinal disorders | 94/238 | 75/240 |
| VomitingGastrointestinal disorders | 88/238 | 34/240 |
| FatigueGeneral disorders | 82/238 | 61/240 |
| Decreased appetiteMetabolism and nutrition disorders | 67/238 | 48/240 |
| DysgeusiaNervous system disorders | 61/238 | 11/240 |
| Mucosal inflammationGeneral disorders | 59/238 | 36/240 |
| HypertensionVascular disorders | 53/238 | 6/240 |
| AstheniaGeneral disorders | 49/238 | 39/240 |
| Age, Customized(Participants) | Sunitinib | Capecitabine | Total |
|---|---|---|---|
| 18 to 44 years | 50 | 70 | 120 |
| 45 to 64 years | 159 | 129 | 288 |
| > = 65 years | 29 | 45 | 74 |
| Sex/Gender, Customized(Participants) | Sunitinib | Capecitabine | Total |
|---|---|---|---|
| Female | 238 | 244 | 482 |
| Male | 0 | 0 | 0 |
Showing the first 100 of 123 sites across 23 countries.
This study is terminated, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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