Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

Number 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). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: Baseline, Week 9, and every 8 weeks up to Month 34

Population: Intent to Treat (ITT) population: all enrolled participants

CTSQ: included 3 multi-item subscales (Expectation of Therapy \[ET\], Satisfaction with Therapy \[SWT\], and Feelings about Side Effects \[FSE\]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.

Time frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination

Population: ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.

CTSQ: included 3 multi-item subscales (Expectation of Therapy \[ET\], Satisfaction with Therapy \[SWT\], and Feelings about Side Effects \[FSE\]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.

Time frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination

Population: ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.

CTSQ: included 3 multi-item subscales (Expectation of Therapy \[ET\], Satisfaction with Therapy \[SWT\], and Feelings about Side Effects \[FSE\]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.

Time frame: Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination

Population: ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.

Time frame: Baseline, every 4 weeks up to Month 31 or early termination

Population: ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.

Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first. DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.

Time frame: Baseline up to Month 34 or early termination

Population: ITT; N=participants with objective response

The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (\>) 6 months according to RECIST. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.

Time frame: Baseline, Week 9, and every 8 weeks up to Month 34

Population: ITT

Number of participants with objective response based assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time frame: Baseline, Week 9, and every 8 weeks up to Month 34

Population: ITT; N=participants who received at least 2 lines of prior chemotherapy for advanced/metastatic disease and had post baseline tumor assessment

Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST. Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.

Time frame: Baseline, every 4 weeks up to Month 34

Population: ITT; Number of participants analyzed equaled (N =) participants who had superficial lesions with post baseline follow-up assessments of those lesions.

Time from randomization to date of death due to any cause. OS (Months)=(death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.

Time frame: Baseline until death (up to Month 34)

Population: ITT

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

Time frame: Baseline up to Month 34

Population: ITT

Probability of survival 1 year after the first dose of study treatment.

Time frame: Baseline up to 1 year

Population: ITT