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.

Intent-to-treat (ITT) population: included all participants who were randomized.

Time from randomization to first documentation of objective tumor progression.

ITT population

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.

ITT population

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.

ITT population. DR was calculated for the subgroup of participants with objective response. 27 participants in the sunitinib arm and 40 participants in the capecitabine arm reported CR or PR response and were analyzed for DR.

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.

The study was stopped early for futility and TTR analysis was not performed.

Average time from randomization to first documentation of death due to any cause.

ITT population

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.

The study was stopped early for futility and EORTC QLQ-C30 analysis was not performed.

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.

The study was stopped early for futility and EORTC QLQ Cancer Module (BR23) analysis was not performed.