A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4

Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death

Population: The intent-to-treat (ITT) population included all patients who were randomized.

Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 \[VEGFR2\] and VEGFR3, VEGF-A, placental growth factor \[PlGF\], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.

Time frame: Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1

Population: ITT. Biomarker data were collected, but since the study was stopped early and there were too few events of OS, PFS, etc, data were not analyzed.

DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as \[the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)\] divided by 30.4.

Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause

Population: ITT. DR was calculated for the subgroup of subjects with objective response. 78 subjects reported CR or PR response and were analyzed for DR in each treatment group.

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 = greater degree of symptoms.

Time frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

Population: ITT. BR23 evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.

EQ-VAS score on the self-rated thermometer, indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.

Time frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

Population: ITT. EQ-VAS evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.

EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.

Time frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

Population: ITT. EORTC QLQ-C30 evaluations were not analyzed since enrollment in this study was terminated early for futility.

EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.

Time frame: Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months

Population: ITT. EQ-5D evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.

Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all 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.

Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months

Population: ITT

OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.

Time frame: From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.

Population: ITT. The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.

Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.

Time frame: Year 1, Year 2

Population: ITT.