A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Phase 3

Terminated

Conditions: Breast Neoplasms

Interventions: Drug: Capecitabine
Drug: Sunitinib malate

Registration Number: NCT00373113

Lead Sponsor: Pfizer

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 482

Inclusion Criteria

breast adenocarcinoma
prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria

Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
Any prior regimen with capecitabine

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Capecitabine	1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
B	Sunitinib malate	37.5 mg daily, continuous dosing

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	From time of randomization to every 6 weeks thereafter through 22 months or until death	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.

Secondary Outcome Measures

Name	Time	Method
Time to Tumor Progression (TTP)	From time of randomization to every 6 weeks thereafter through 22 months	Time from randomization to first documentation of objective tumor progression.
Number of Participants With Overall Response (OR)	From time of randomization to every 6 weeks thereafter through 22 months	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.
Duration of Response (DR)	From time of randomization to every 6 weeks thereafter through 22 months or death	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 to Tumor Response (TTR)	From time of randomization to every 6 weeks thereafter through 22 months	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.
Overall Survival (OS)	From time of randomization until death	Average time from randomization to first documentation of death due to any cause.
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)	From Day 1 of Cycle 1, then odd numbered cycles thereafter	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.
EORTC QLQ Breast Cancer Module (BR23)	From Day 1 of Cycle 1, then odd numbered cycles thereafter	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.