Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: From screening until 28 days post last dose of study drug

Population: Safety population included all participants enrolled in the study who received at least 1 dose of study medication.

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Time frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)

Population: Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).

Concentration values below the lower limit of quantification were taken as zero.

Time frame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6

Population: PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)

Population: Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.

Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.

Time frame: Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1

Population: Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.

Ctrough = the concentration prior to study medication administration.

Time frame: Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6

Population: Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death).

Time frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)

Population: Study population included all participants who received at least 1 dose of study medication.

Time frame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6

Population: Data not analyzed since paclitaxel was not administered in the study.