Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00471276
• Collaborator: (none)
• Enrollment: 83
• Locations: 31
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: sunitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: sunitinib; sunitinib (Sutent), 37.5 mg, daily dosing; Other Names: Sutent, sunitinib

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Objective Response [Baseline, Week 9, and every 8 weeks up to Month 34]

   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.

Secondary Outcome Measures

1. Number of Participants With Clinical Benefit [Baseline, Week 9, and every 8 weeks up to Month 34]

   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.

2. Number of Participants With Objective Response of Superficial Lesions [Baseline, every 4 weeks up to Month 34]

   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.

3. Progression-Free Survival (PFS) [Baseline up to Month 34]

   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.

4. Duration of Response (DR) [Baseline up to Month 34 or early termination]

   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.

5. Overall Survival (OS) [Baseline until death (up to Month 34)]

   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.

6. Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy [Baseline, Week 9, and every 8 weeks up to Month 34]

   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.

7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score [Baseline, every 4 weeks up to Month 31 or early termination]

   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.

8. Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image [Baseline, every 4 weeks up to Month 31 or early termination]

   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.

9. Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective [Baseline, every 4 weeks up to Month 31 or early termination]

   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.

10. Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment [Baseline, every 4 weeks up to Month 31 or early termination]

    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.

11. Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning [Baseline, every 4 weeks up to Month 31 or early termination]

    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.

12. Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms [Baseline, every 4 weeks up to Month 31 or early termination]

    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.

13. Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms [Baseline, every 4 weeks up to Month 31 or early termination]

    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.

14. Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects [Baseline, every 4 weeks up to Month 31 or early termination]

    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.

15. Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss [Baseline, every 4 weeks up to Month 31 or early termination]

    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.

16. Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy [Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination]

    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.

17. Change From Baseline in CTSQ Score: Feelings About Side Effects [Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination]

    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.

18. Change From Baseline in CTSQ Score: Satisfaction With Therapy [Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination]

    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.

Other Outcome Measures

1. 1-Year Survival Probability [Baseline up to 1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of breast cancer

• Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy

• Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

• Inflammatory breast cancer

• Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bakersfield	California	United States	93309
2	Pfizer Investigational Site	Burbank	California	United States	91505-4866
3	Pfizer Investigational Site	Fountain Valley	California	United States	92708
4	Pfizer Investigational Site	Hawthorne	California	United States	90250
5	Pfizer Investigational Site	Long Beach	California	United States	90806
6	Pfizer Investigational Site	Boynton Beach	Florida	United States	33435
7	Pfizer Investigational Site	Zion	Illinois	United States	60099
8	Pfizer Investigational Site	Louisville	Kentucky	United States	40207
9	Pfizer Investigational Site	Kalamazoo	Michigan	United States	49007
10	Pfizer Investigational Site	Maple Grove	Minnesota	United States	55369
11	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55454
12	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55455
13	Pfizer Investigational Site	Columbia	Missouri	United States	65203
14	Pfizer Investigational Site	Asheville	North Carolina	United States	28806
15	Pfizer Investigational Site	Chapel Hill	North Carolina	United States	27599
16	Pfizer Investigational Site	Kernersville	North Carolina	United States	27284
17	Pfizer Investigational Site	Lexington	North Carolina	United States	27292
18	Pfizer Investigational Site	North Wilkesboro	North Carolina	United States	28659
19	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27103
20	Pfizer Investigational Site	Bismarck	North Dakota	United States	58501
21	Pfizer Investigational Site	Franklin	Tennessee	United States	37067
22	Pfizer Investigational Site	Gallatin	Tennessee	United States	37066
23	Pfizer Investigational Site	Hermitage	Tennessee	United States	37076
24	Pfizer Investigational Site	Lebanon	Tennessee	United States	37087
25	Pfizer Investigational Site	Murfreesboro	Tennessee	United States	37130
26	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
27	Pfizer Investigational Site	Nashville	Tennessee	United States	37205
28	Pfizer Investigational Site	Nashville	Tennessee	United States	37207
29	Pfizer Investigational Site	Nashville	Tennessee	United States	37211
30	Pfizer Investigational Site	Smyrna	Tennessee	United States	37167
31	Pfizer Investigational Site	Everett	Washington	United States	98201

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00471276
• Other Study ID Numbers: A6181068
• First Posted: May 9, 2007
• Last Update Posted: Jul 25, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Metastatic Breast Cancer
• Additional relevant MeSH terms: Breast Neoplasms; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Period Title: Overall Study
STARTED	83
COMPLETED	0
NOT COMPLETED	83

Baseline Characteristics

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Overall Participants	83
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.5 (10.9)
Sex: Female, Male (Count of Participants)
Female	83 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Objective Response
Description	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

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population: all enrolled participants

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	83
Number [Participants]	7 8.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Objective Response Rate (percent)
	Estimated Value	8.4
	Confidence Interval	(2-Sided) 95%; 3.5 to 16.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Clinical Benefit
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	83
Number [Participants]	9 10.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Objective Response Rate (percent)
	Estimated Value	10.8
	Confidence Interval	(2-Sided) 95%; 5.1 to 19.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Objective Response of Superficial Lesions
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	15
Number [Participants]	3 3.6%

4. Secondary Outcome

Title	Progression-Free Survival (PFS)
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	83
Median (95% Confidence Interval) [Months]	3.6

5. Secondary Outcome

Title	Duration of Response (DR)
Description	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

Outcome Measure Data

Analysis Population Description

ITT; N=participants with objective response

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	7
Median (Full Range) [Weeks]	3.4

6. Secondary Outcome

Title	Overall Survival (OS)
Description	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)

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	83
Median (95% Confidence Interval) [Months]	15.6

7. Secondary Outcome

Title	Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	3
Number [Participants]	1 1.2%

8. Secondary Outcome

Title	Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	76
Week 4 (Cycle 2/Day 1) (n=64)	0.0
Month 2 (Cycle 3/Day 1) (n=44)	-8.3
Month 3 (Cycle 4/Day 1) (n=34)	-16.7
Month 4 (Cycle 5/Day 1) (n=19)	-8.3
Month 5 (Cycle 6/Day 1) (n=16)	-8.3
Baseline (Cycle 1/Day 1) (n=76)	66.7

9. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	77
Week 4 (Cycle 2/Day 1) (n=60)	0.0
Month 2 (Cycle 3/Day 1) (n=38)	0.0
Month 3 (Cycle 4/Day 1) (n=29)	0.0
Month 4 (Cycle 5/Day 1) (n=17)	0.0
Month 5 (Cycle 6/Day 1) (n=14)	0.0
Baseline (Cycle 1/Day 1) (n=77)	83.3

10. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	76
Week 4 (Cycle 2/Day 1) (n=59)	0.0
Month 2 (Cycle 3/Day 1) (n=38)	-33.3
Month 3 (Cycle 4/Day 1) (n=29)	-33.3
Month 4 (Cycle 5/Day 1) (n=17)	0.0
Month 5 (Cycle 6/Day 1) (n=14)	-16.7
Baseline (Cycle 1/Day 1) (n=76)	66.7

11. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	32
Week 4 (Cycle 2/Day 1) (n=17)	0.0
Month 2 (Cycle 3/Day 1) (n=10)	0.0
Month 3 (Cycle 4/Day 1) (n=6)	0.0
Month 4 (Cycle 5/Day 1) (n=5)	0.0
Month 5 (Cycle 6/Day 1) (n=4)	0.0
Baseline (Cycle 1/Day 1) (n=32)	33.3

12. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	72
Week 4 (Cycle 2/Day 1) (n=56)	0.0
Month 2 (Cycle 3/Day 1) (n=36)	0.0
Month 3 (Cycle 4/Day 1) (n=25)	0.0
Month 4 (Cycle 5/Day 1) (n=15)	0.0
Month 5 (Cycle 6/Day 1) (n=12)	0.0
Baseline (Cycle 1/Day 1) (n=72)	100.0

13. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	77
Week 4 (Cycle 2/Day 1) (n=62)	0.0
Month 2 (Cycle 3/Day 1) (n=40)	0.0
Month 3 (Cycle 4/Day 1) (n=30)	0.0
Month 4 (Cycle 5/Day 1) (n=17)	0.0
Month 5 (Cycle 6/Day 1) (n=14)	0.0
Baseline (Cycle 1/Day 1) (n=77)	11.1

14. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	76
Week 4 (Cycle 2/Day 1) (n=61)	0.0
Month 2 (Cycle 3/Day 1) (n=39)	0.0
Month 3 (Cycle 4/Day 1) (n=30)	0.0
Month 4 (Cycle 5/Day 1) (n=17)	0.0
Month 5 (Cycle 6/Day 1) (n=14)	0.0
Baseline (Cycle 1/Day 1) (n=76)	8.3

15. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	77
Week 4 (Cycle 2/Day 1) (n=62)	14.3
Month 2 (Cycle 3/Day 1) (n=40)	19.0
Month 3 (Cycle 4/Day 1) (n=29)	14.3
Month 4 (Cycle 5/Day 1) (n=17)	23.8
Month 5 (Cycle 6/Day 1) (n=14)	19.0
Baseline (Cycle 1/Day 1) (n=77)	14.3

16. Secondary Outcome

Title	Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	25
Week 4 (Cycle 2/Day 1) (n=5)	0.0
Month 2 (Cycle 3/Day 1) (n=8)	0.0
Month 3 (Cycle 4/Day 1) (n=6)	0.0
Month 4 (Cycle 5/Day 1) (n=5)	0.0
Month 5 (Cycle 6/Day 1) (n=4)	0.0
Baseline (Cycle 1/Day 1) (n=25)	0.0

17. Secondary Outcome

Title	Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	59
Baseline (Cycle 1/Day 1) (n=59)	70.00
Cycle 1/Day 15 (n=2)	20.00
Week 4 (Cycle 2/Day 1) (n=48)	0.00
Week 8 (Cycle 3/Day 1) (n=31)	5.00
Month 4 (Cycle 5/Day 1) (n=11)	5.00
Month 6 (Cycle 7/Day 1) (n=2)	17.50

18. Secondary Outcome

Title	Change From Baseline in CTSQ Score: Feelings About Side Effects
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	58
Cycle 1/Day 15 (n=2)	3.13
Week 4 (Cycle 2/Day 1) (n=47)	0.00
Week 8 (Cycle 3/Day 1) (n=31)	0.00
Month 4 (Cycle 5/Day 1) (n=12)	0.00
Month 6 (Cycle 7/Day 1) (n=2)	-6.25
Baseline (Cycle 1/Day 1) (n=58)	62.50

19. Secondary Outcome

Title	Change From Baseline in CTSQ Score: Satisfaction With Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	59
Cycle 1/Day 15 (n=2)	8.93
Week 4 (Cycle 2/Day 1) (n=48)	10.71
Week 8 (Cycle 3/Day 1) (n=31)	7.14
Month 4 (Cycle 5/Day 1) (n=12)	11.79
Month 6 (Cycle 7/Day 1) (n=2)	-1.79
Baseline (Cycle 1/Day 1) (n=59)	71.43

20. Other Pre-specified Outcome

Title	1-Year Survival Probability
Description	Probability of survival 1 year after the first dose of study treatment.
Time Frame	Baseline up to 1 year

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
Measure Participants	83
Number (95% Confidence Interval) [Percentage of participants]	65.0 78.3%

Adverse Events

Adverse Event Reporting Description	The same event may have appeared as both an adverse event (AE) and a serious AE (SAE). However, what was presented were distinct events. An event may have been categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
All Cause Mortality
	Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	13/83 (15.7%)
Cardiac disorders
Cardiac failure congestive	1/83 (1.2%)
Endocrine disorders
Hypothyroidism	1/83 (1.2%)
Gastrointestinal disorders
Nausea	2/83 (2.4%)
Vomiting	2/83 (2.4%)
Diarrhea	1/83 (1.2%)
Gastrointestinal Haemorrhage	1/83 (1.2%)
General disorders
Asthenia	1/83 (1.2%)
Hepatobiliary disorders
Hyperbilirubinaemia	1/83 (1.2%)
Infections and infestations
Anal abscess	1/83 (1.2%)
Metabolism and nutrition disorders
Dehydration	3/83 (3.6%)
Decreased appetite	1/83 (1.2%)
Failure to thrive	1/83 (1.2%)
Musculoskeletal and connective tissue disorders
Bone pain	1/83 (1.2%)
Nervous system disorders
Aphasia	1/83 (1.2%)
Ataxia	1/83 (1.2%)
Psychiatric disorders
Confusional state	2/83 (2.4%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	2/83 (2.4%)
Pleural effusion	1/83 (1.2%)
Vascular disorders
Hypertension	2/83 (2.4%)
Deep vein thrombosis	1/83 (1.2%)
Other (Not Including Serious) Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	83/83 (100%)
Blood and lymphatic system disorders
Anaemia	20/83 (24.1%)
Leukopenia	33/83 (39.8%)
Neutropenia	37/83 (44.6%)
Thrombocytopenia	34/83 (41%)
Endocrine disorders
Hypothyroidism	8/83 (9.6%)
Eye disorders
Lacrimation increased	5/83 (6%)
Vision blurred	7/83 (8.4%)
Gastrointestinal disorders
Abdominal pain	5/83 (6%)
Abdominal pain upper	5/83 (6%)
Constipation	12/83 (14.5%)
Diarrhoea	44/83 (53%)
Dry mouth	10/83 (12%)
Dyspepsia	14/83 (16.9%)
Gastrooesophageal reflux disease	9/83 (10.8%)
Glossodynia	5/83 (6%)
Nausea	40/83 (48.2%)
Oral pain	12/83 (14.5%)
Stomatitis	15/83 (18.1%)
Vomiting	27/83 (32.5%)
General disorders
Asthenia	9/83 (10.8%)
Fatigue	50/83 (60.2%)
Mucosal inflammation	5/83 (6%)
Pyrexia	5/83 (6%)
Infections and infestations
Urinary tract infection	12/83 (14.5%)
Injury, poisoning and procedural complications
Contusion	7/83 (8.4%)
Investigations
Alanine aminotransferase increased	8/83 (9.6%)
Aspartate aminotransferase increased	10/83 (12%)
Blood alkaline phosphatase increased	7/83 (8.4%)
Blood creatinine increased	5/83 (6%)
Weight decreased	9/83 (10.8%)
Metabolism and nutrition disorders
Decreased appetite	36/83 (43.4%)
Dehydration	13/83 (15.7%)
Hypokalaemia	13/83 (15.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	15/83 (18.1%)
Back pain	11/83 (13.3%)
Bone pain	10/83 (12%)
Muscular weakness	5/83 (6%)
Musculoskeletal chest pain	6/83 (7.2%)
Musculoskeletal pain	6/83 (7.2%)
Pain in extremity	10/83 (12%)
Nervous system disorders
Dizziness	9/83 (10.8%)
Dysgeusia	26/83 (31.3%)
Headache	14/83 (16.9%)
Psychiatric disorders
Insomnia	10/83 (12%)
Respiratory, thoracic and mediastinal disorders
Cough	14/83 (16.9%)
Dyspnoea	11/83 (13.3%)
Dyspnoea exertional	7/83 (8.4%)
Oropharyngeal pain	6/83 (7.2%)
Skin and subcutaneous tissue disorders
Acne	7/83 (8.4%)
Alopecia	7/83 (8.4%)
Dry skin	9/83 (10.8%)
Hair colour changes	6/83 (7.2%)
Nail disorder	5/83 (6%)
Palmar-plantar erythrodysaesthesia syndrome	17/83 (20.5%)
Pruritus	9/83 (10.8%)
Rash	14/83 (16.9%)
Skin discolouration	5/83 (6%)
Yellow skin	11/83 (13.3%)
Vascular disorders
Hypertension	21/83 (25.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.