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SUN 1064: Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00393939
Collaborator
(none)
594
Enrollment
144
Locations
2
Arms
52.9
Duration (Months)
4.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
594 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: Sunitinib malate
Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
Active Comparator: B

Drug: Taxotere
Docetaxel 100 mg/m2 every 3 weeks in the comparator arm

Outcome Measures

Primary Outcome Measures

  1. Progression-Free Survival (PFS) [Baseline up to Month 33]

    PFS defined as time from date of randomization to date of the 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.

Secondary Outcome Measures

  1. Percentage of Participants With Objective Response [Baseline up to Month 33]

    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). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.

  2. Duration of Response (DR) [Baseline up to Month 33]

    DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.

  3. Overall Survival (OS) [Baseline to date of death from any cause (up to Month 33)]

    Time from randomization to date of death due to any cause. OS calculated as (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.

  4. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score [Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)]

    EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.

  5. Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score [Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)]

    EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.

  6. Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score [Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)]

    EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled 'best imaginable health state' and 'worst imaginable health state'. Change from baseline = score for Cycle/Day minus baseline score.

Eligibility Criteria

Criteria

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

  • Breast cancer with evidence of unresectable locally recurrent, or metastatic disease

  • Her-2 negative tumors

Exclusion Criteria:

  • Patients for whom docetaxel is contraindicated

  • Clinical presentation of inflammatory carcinoma with no other measurable disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Berkely California United States 94704
2 Pfizer Investigational Site Shreveport Louisiana United States 71103
3 Pfizer Investigational Site Beaumont Texas United States 77701
4 Pfizer Investigational Site Burleson Texas United States 76028
5 Pfizer Investigational Site Cleburne Texas United States 76031
6 Pfizer Investigational Site Fort Worth Texas United States 76104
7 Pfizer Investigational Site Mineral Wells Texas United States 76067
8 Pfizer Investigational Site Weatherford Texas United States 76086
9 Pfizer Investigational Site La Plata Buenos Aires Argentina B1902CMV
10 Pfizer Investigational Site Pergamino Buenos Aires Argentina B2700CPM
11 Pfizer Investigational Site Burnos Aires Argentina C1426ANZ
12 Pfizer Investigational Site Tweed Heads New South Wales Australia 2485
13 Pfizer Investigational Site Redcliffe Queensland Australia 4020
14 Pfizer Investigational Site Adelaide South Australia Australia 5000
15 Pfizer Investigational Site Brighton Victoria Australia 3186
16 Pfizer Investigational Site Malvern Victoria Australia 3144
17 Pfizer Investigational Site Ringwood East Victoria Australia 3135
18 Pfizer Investigational Site Perth Western Australia Australia 6000
19 Pfizer Investigational Site Salzburg Austria A-5020
20 Pfizer Investigational Site Wien Austria A-1090
21 Pfizer Investigational Site Wien Austria A-1100
22 Pfizer Investigational Site Wien Austria A-1160
23 Pfizer Investigational Site Brasschaat Belgium 2930
24 Pfizer Investigational Site Bruxelles Belgium 1000
25 Pfizer Investigational Site Verviers Belgium 4800
26 Pfizer Investigational Site Surrey British Columbia Canada V3V 1Z2
27 Pfizer Investigational Site Hamilton Ontario Canada L8V 5C2
28 Pfizer Investigational Site Kingston Ontario Canada K7L 2V7
29 Pfizer Investigational Site Kingston Ontario Canada K7L 5P9
30 Pfizer Investigational Site Sudbury Ontario Canada P3E 5J1
31 Pfizer Investigational Site Bogota Cundinamarca Colombia
32 Pfizer Investigational Site Pereira Risaralda Colombia 0
33 Pfizer Investigational Site Cali Valle del Cauca Colombia 0
34 Pfizer Investigational Site Brno Czech Republic 656 53
35 Pfizer Investigational Site Novy Jicin Czech Republic 741 01
36 Pfizer Investigational Site Praha 5 Czech Republic 150 06
37 Pfizer Investigational Site Praha 8 Czech Republic 180 00
38 Pfizer Investigational Site Tampere Finland 33520
39 Pfizer Investigational Site Turku Finland 20520
40 Pfizer Investigational Site Bordeaux CEDEX France 33000
41 Pfizer Investigational Site Dijon France 21079
42 Pfizer Investigational Site NANTES Cedex 2 France 44202
43 Pfizer Investigational Site Reims France 51100
44 Pfizer Investigational Site Saint Cloud France 92210
45 Pfizer Investigational Site Saint-Priest-en-Jarez Cedex France 42270
46 Pfizer Investigational Site Strasbourg France 67000
47 Pfizer Investigational Site Tours France 37000
48 Pfizer Investigational Site Villejuif France 94805
49 Pfizer Investigational Site Berlin Germany 12200
50 Pfizer Investigational Site Chemnitz Germany 09116
51 Pfizer Investigational Site Essen Germany 45122
52 Pfizer Investigational Site Hildesheim Germany 31134
53 Pfizer Investigational Site Karlsruhe Germany 76135
54 Pfizer Investigational Site Leverkusen Germany 51375
55 Pfizer Investigational Site Magdeburg Germany 39108
56 Pfizer Investigational Site Marburg Germany 35043
57 Pfizer Investigational Site Oldenburg Germany 26133
58 Pfizer Investigational Site Ravensburg Germany 88212
59 Pfizer Investigational Site Rosenheim Germany 83022
60 Pfizer Investigational Site Wuerzburg Germany 97080
61 Pfizer Investigational Site Budapest Hungary 1122
62 Pfizer Investigational Site Budapest Hungary 1145
63 Pfizer Investigational Site Kaposvar Hungary 7400
64 Pfizer Investigational Site Szentes Hungary 6600
65 Pfizer Investigational Site Dublin Ireland 4
66 Pfizer Investigational Site Dublin Ireland 7
67 Pfizer Investigational Site Dublin Ireland 8
68 Pfizer Investigational Site Galway Ireland
69 Pfizer Investigational Site Catania Italy 95126
70 Pfizer Investigational Site Cattolica (RN) Italy 47841
71 Pfizer Investigational Site Cefalu' (PA) Italy 90015
72 Pfizer Investigational Site Chieti Scalo Italy 66013
73 Pfizer Investigational Site Lecce Italy 73100
74 Pfizer Investigational Site Livorno Italy 57123
75 Pfizer Investigational Site Macerata Italy 62100
76 Pfizer Investigational Site Napoli Italy 80131
77 Pfizer Investigational Site Palermo Italy 90146
78 Pfizer Investigational Site Pavia Italy 27100
79 Pfizer Investigational Site Rimini Italy 47900
80 Pfizer Investigational Site Roma Italy 00144
81 Pfizer Investigational Site Goyang-si Gyeonggi-do Korea, Republic of 410-769
82 Pfizer Investigational Site Seoul Korea, Republic of 120-752
83 Pfizer Investigational Site Seoul Korea, Republic of 138-736
84 Pfizer Investigational Site Nijmegen Netherlands 6525 GA
85 Pfizer Investigational Site Utrecht Netherlands 3584 CX
86 Pfizer Investigational Site Venlo Netherlands 5912 BL
87 Pfizer Investigational Site Panama Panama
88 Pfizer Investigational Site Gdansk Poland 80-952
89 Pfizer Investigational Site Lubin Poland 59-300
90 Pfizer Investigational Site Poznan Poland 61-878
91 Pfizer Investigational Site Rybnik Poland 44-200
92 Pfizer Investigational Site Warszawa Poland 02-781
93 Pfizer Investigational Site Coimbra Portugal 3000-075
94 Pfizer Investigational Site Lisboa Portugal 1099-023
95 Pfizer Investigational Site Porto Portugal 4200-072
96 Pfizer Investigational Site Santa Maria da Feira Portugal 4520-211
97 Pfizer Investigational Site Cluj Napoca Cluj Romania 400015
98 Pfizer Investigational Site Cluj Napoca Cluj Romania 40006
99 Pfizer Investigational Site Craiova Dolj Romania 200642
100 Pfizer Investigational Site Bucuresti Sector 2 Romania 022328
101 Pfizer Investigational Site Kuzmolovo, Vsevolozhsk district Leningrad region Russian Federation 188663
102 Pfizer Investigational Site Moscow Russian Federation 115478
103 Pfizer Investigational Site Moscow Russian Federation 143423
104 Pfizer Investigational Site Saint Petersburg Russian Federation 195067
105 Pfizer Investigational Site St. Petersburg Russian Federation 197758
106 Pfizer Investigational Site Banska Bystrica Slovakia 975 17
107 Pfizer Investigational Site Bratislava Slovakia 812 50
108 Pfizer Investigational Site Bratislava Slovakia 833 10
109 Pfizer Investigational Site Nitra Slovakia 949 01
110 Pfizer Investigational Site Palma de Mallorca Baleares Spain 07010
111 Pfizer Investigational Site Santiago de Compostela La Coruña Spain 15706
112 Pfizer Investigational Site Dos Hermanas Sevilla Spain 41700
113 Pfizer Investigational Site Barcelona Spain 08035
114 Pfizer Investigational Site Madrid Spain 28034
115 Pfizer Investigational Site Santa Cruz de Tenerife Spain 38320
116 Pfizer Investigational Site Toledo Spain 45004
117 Pfizer Investigational Site Valencia Spain 46009
118 Pfizer Investigational Site Valencia Spain 46010
119 Pfizer Investigational Site Valencia Spain 46014
120 Pfizer Investigational Site Zaragoza Spain 50009
121 Pfizer Investigational Site Helsingborg Sweden 251 87
122 Pfizer Investigational Site Karlstad Sweden 651 85
123 Pfizer Investigational Site Stockholm Sweden 118 83
124 Pfizer Investigational Site Stockholm Sweden 171 76
125 Pfizer Investigational Site Uppsala Sweden 751 85
126 Pfizer Investigational Site Ankara Turkey 06100
127 Pfizer Investigational Site Gaziantep Turkey
128 Pfizer Investigational Site Istanbul Turkey
129 Pfizer Investigational Site Dnipropetrovsk Ukraine 49102
130 Pfizer Investigational Site Donetsk Ukraine 83092
131 Pfizer Investigational Site Ivano-Frankivsk Ukraine 76018
132 Pfizer Investigational Site Kyiv Ukraine 01103
133 Pfizer Investigational Site Kyiv Ukraine 03115
134 Pfizer Investigational Site Lviv Ukraine 79031
135 Pfizer Investigational Site Cheltenham Gloucestershire United Kingdom GL53 7AN
136 Pfizer Investigational Site Maidstone Kent United Kingdom ME16 9QQ
137 Pfizer Investigational Site Manchester M20 4bx United Kingdom
138 Pfizer Investigational Site Wirral Merseyside United Kingdom CH63 4JY
139 Pfizer Investigational Site Shrewsbury Shropshire United Kingdom SY3 8XQ
140 Pfizer Investigational Site Telford Shropshire United Kingdom TF1 6TF
141 Pfizer Investigational Site Guildford Surrey United Kingdom GU2 5XX
142 Pfizer Investigational Site Worthing West Sussex United Kingdom BN11 2DH
143 Pfizer Investigational Site London United Kingdom W6 8RF
144 Pfizer Investigational Site Wolverhampton United Kingdom WV10 0QP

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00393939
Other Study ID Numbers:
  • A6181064
First Posted:
Oct 31, 2006
Last Update Posted:
Jul 19, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Pfizer
advanced breast cancer
sunitinib
docetaxel
Phase 3
Additional relevant MeSH terms:
Breast Neoplasms
Docetaxel
Sunitinib

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 594 participants enrolled in study; 1 participant withdrew consent prior to treatment. In accordance with French law, that participant's data was not used in the analyses.
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Period Title: Overall Study
STARTED 296 297
Treated 295 293
COMPLETED 0 0
NOT COMPLETED 296 297

Baseline Characteristics

Arm/Group Title Docetaxel + Sunitinib Docetaxel Total
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks Total of all reporting groups
Overall Participants 296 297 593
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
54.3
(9.74)
55.1
(10.36)
54.7
(10.05)
Sex: Female, Male (Count of Participants)
Female
296
100%
297
100%
593
100%
Male
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Progression-Free Survival (PFS)
Description PFS defined as time from date of randomization to date of the 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 33

Outcome Measure Data

Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 296 297
Independent radiology assessment
8.6
8.3
Investigator's assessment
8.2
6.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Sunitinib, Docetaxel
Comments Independent radiology assessment
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2651
Comments 1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.9222
Confidence Interval (2-Sided) 95%
0.7156 to 1.1885
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel + Sunitinib, Docetaxel
Comments Investigator's assessment
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0753
Comments 1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8560
Confidence Interval (2-Sided) 95%
0.6921 to 1.0589
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Percentage of Participants With Objective Response
Description 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). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.
Time Frame Baseline up to Month 33

Outcome Measure Data

Analysis Population Description
ITT population
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 296 297
Independent radiology assessment
51.0
17.2%
39.1
13.2%
Investigator's assessment
52.7
17.8%
43.8
14.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Sunitinib, Docetaxel
Comments Independent radiology assessment
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0018
Comments 1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
1.17 to 2.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel + Sunitinib, Docetaxel
Comments Investigator's assessment
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0172
Comments 1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
1.03 to 2.02
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Duration of Response (DR)
Description DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.
Time Frame Baseline up to Month 33

Outcome Measure Data

Analysis Population Description
ITT population. Number of participants analyzed = number of participants with confirmed objective tumor response.
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 156 130
Independent radiology asssessment (n=151, 116)
7.5
7.2
Investigator's assessment (n=156, 130)
6.9
5.8
4. Secondary Outcome
Title Overall Survival (OS)
Description Time from randomization to date of death due to any cause. OS calculated as (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 to date of death from any cause (up to Month 33)

Outcome Measure Data

Analysis Population Description
ITT population
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 296 297
Median (95% Confidence Interval) [months]
26.0
28.9
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Sunitinib, Docetaxel
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8933
Comments 1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)
Method Log Rank
Comments
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1539
Confidence Interval (2-Sided) 95%
0.9209 to 1.4458
Parameter Dispersion Type:
Value:
Estimation Comments
5. 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 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.
Time Frame Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

Outcome Measure Data

Analysis Population Description
ITT population; data not analyzed because study failed its primary endpoint.
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 0 0
6. Secondary Outcome
Title Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score
Description EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.
Time Frame Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

Outcome Measure Data

Analysis Population Description
ITT population; data not analyzed because study failed its primary endpoint.
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 0 0
7. Secondary Outcome
Title Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score
Description EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled 'best imaginable health state' and 'worst imaginable health state'. Change from baseline = score for Cycle/Day minus baseline score.
Time Frame Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

Outcome Measure Data

Analysis Population Description
ITT population; data not analyzed because study failed its primary endpoint.
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
Measure Participants 0 0

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title Docetaxel + Sunitinib Docetaxel
Arm/Group Description Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib). Docetaxel 100 mg/m^2 every 3 weeks
All Cause Mortality
Docetaxel + Sunitinib Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Docetaxel + Sunitinib Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 112/295 (38%) 79/293 (27%)
Blood and lymphatic system disorders
Anaemia 4/295 (1.4%) 2/293 (0.7%)
Febrile neutropenia 20/295 (6.8%) 13/293 (4.4%)
Leukopenia 5/295 (1.7%) 7/293 (2.4%)
Lymphatic disorder 1/295 (0.3%) 0/293 (0%)
Neutropenia 11/295 (3.7%) 16/293 (5.5%)
Thrombocytopenia 1/295 (0.3%) 0/293 (0%)
Cardiac disorders
Angina pectoris 0/295 (0%) 1/293 (0.3%)
Atrial fibrillation 1/295 (0.3%) 0/293 (0%)
Atrioventricular block 1/295 (0.3%) 0/293 (0%)
Cardiac arrest 1/295 (0.3%) 0/293 (0%)
Cardiac disorder 1/295 (0.3%) 0/293 (0%)
Cardiac failure 1/295 (0.3%) 0/293 (0%)
Myocardial infarction 0/295 (0%) 1/293 (0.3%)
Myocardial ischaemia 1/295 (0.3%) 0/293 (0%)
Pericardial effusion 1/295 (0.3%) 0/293 (0%)
Ear and labyrinth disorders
Vertigo 1/295 (0.3%) 1/293 (0.3%)
Eye disorders
Conjunctivitis 1/295 (0.3%) 0/293 (0%)
Visual impairment 1/295 (0.3%) 0/293 (0%)
Gastrointestinal disorders
Abdominal pain 1/295 (0.3%) 1/293 (0.3%)
Anal fistula 0/295 (0%) 1/293 (0.3%)
Cheilitis 1/295 (0.3%) 0/293 (0%)
Diarrhoea 6/295 (2%) 2/293 (0.7%)
Diverticular perforation 0/295 (0%) 1/293 (0.3%)
Dysphagia 1/295 (0.3%) 0/293 (0%)
Nausea 2/295 (0.7%) 6/293 (2%)
Oesophagitis ulcerative 1/295 (0.3%) 0/293 (0%)
Pancreatitis 1/295 (0.3%) 0/293 (0%)
Periproctitis 2/295 (0.7%) 0/293 (0%)
Pneumoperitoneum 1/295 (0.3%) 0/293 (0%)
Stomatitis 3/295 (1%) 2/293 (0.7%)
Vomiting 4/295 (1.4%) 4/293 (1.4%)
General disorders
Adverse drug reaction 1/295 (0.3%) 0/293 (0%)
Asthenia 4/295 (1.4%) 1/293 (0.3%)
Chest pain 1/295 (0.3%) 0/293 (0%)
Death 1/295 (0.3%) 0/293 (0%)
Disease progression 6/295 (2%) 4/293 (1.4%)
Fatigue 2/295 (0.7%) 1/293 (0.3%)
General physical health deterioration 5/295 (1.7%) 4/293 (1.4%)
Impaired healing 1/295 (0.3%) 0/293 (0%)
Mucosal inflammation 2/295 (0.7%) 1/293 (0.3%)
Oedema peripheral 0/295 (0%) 1/293 (0.3%)
Pain 0/295 (0%) 2/293 (0.7%)
Pyrexia 10/295 (3.4%) 5/293 (1.7%)
Device dislocation 1/295 (0.3%) 0/293 (0%)
Hepatobiliary disorders
Cholestasis 1/295 (0.3%) 0/293 (0%)
Jaundice 0/295 (0%) 1/293 (0.3%)
Immune system disorders
Hypersensitivity 1/295 (0.3%) 0/293 (0%)
Infections and infestations
Anal abscess 1/295 (0.3%) 0/293 (0%)
Bronchitis 1/295 (0.3%) 1/293 (0.3%)
Catheter site infection 2/295 (0.7%) 1/293 (0.3%)
Cellulitis 1/295 (0.3%) 0/293 (0%)
Clostridial infection 0/295 (0%) 1/293 (0.3%)
Cystitis 0/295 (0%) 3/293 (1%)
Diverticulitis 0/295 (0%) 1/293 (0.3%)
Erysipelas 1/295 (0.3%) 1/293 (0.3%)
Gastroenteritis viral 0/295 (0%) 1/293 (0.3%)
Groin infection 1/295 (0.3%) 0/293 (0%)
Haematoma infection 1/295 (0.3%) 0/293 (0%)
Infection 2/295 (0.7%) 3/293 (1%)
Localised infection 0/295 (0%) 1/293 (0.3%)
Lung infection 1/295 (0.3%) 0/293 (0%)
Nasopharyngitis 0/295 (0%) 1/293 (0.3%)
Necrotising fasciitis 1/295 (0.3%) 0/293 (0%)
Neutropenic infection 3/295 (1%) 3/293 (1%)
Neutropenic sepsis 3/295 (1%) 3/293 (1%)
Osteomyelitis 1/295 (0.3%) 0/293 (0%)
Peridiverticular abscess 0/295 (0%) 1/293 (0.3%)
Pneumocystis jiroveci pneumonia 1/295 (0.3%) 0/293 (0%)
Pneumonia 2/295 (0.7%) 5/293 (1.7%)
Pneumonia primary atypical 1/295 (0.3%) 0/293 (0%)
Pyelonephritis 1/295 (0.3%) 0/293 (0%)
Rectal abscess 1/295 (0.3%) 0/293 (0%)
Respiratory tract infection 1/295 (0.3%) 0/293 (0%)
Sepsis 1/295 (0.3%) 0/293 (0%)
Septic shock 2/295 (0.7%) 1/293 (0.3%)
Sinusitis 1/295 (0.3%) 0/293 (0%)
Streptococcal bacteraemia 1/295 (0.3%) 0/293 (0%)
Subcutaneous abscess 2/295 (0.7%) 0/293 (0%)
Tooth abscess 1/295 (0.3%) 0/293 (0%)
Urinary tract infection 1/295 (0.3%) 1/293 (0.3%)
Device related infection 2/295 (0.7%) 0/293 (0%)
Paronychia 0/295 (0%) 1/293 (0.3%)
Injury, poisoning and procedural complications
Contusion 2/295 (0.7%) 0/293 (0%)
Fall 2/295 (0.7%) 1/293 (0.3%)
Femur fracture 0/295 (0%) 1/293 (0.3%)
Overdose 1/295 (0.3%) 0/293 (0%)
Periorbital haematoma 1/295 (0.3%) 0/293 (0%)
Upper limb fracture 0/295 (0%) 1/293 (0.3%)
Investigations
Alanine aminotransferase increased 1/295 (0.3%) 0/293 (0%)
Aspartate aminotransferase increased 1/295 (0.3%) 0/293 (0%)
Blood alkaline phosphatase increased 1/295 (0.3%) 0/293 (0%)
Blood bilirubin increased 1/295 (0.3%) 0/293 (0%)
Blood culture positive 0/295 (0%) 1/293 (0.3%)
Blood thyroid stimulating hormone increased 1/295 (0.3%) 0/293 (0%)
Gamma-glutamyltransferase increased 1/295 (0.3%) 0/293 (0%)
Metabolism and nutrition disorders
Decreased appetite 2/295 (0.7%) 0/293 (0%)
Dehydration 3/295 (1%) 1/293 (0.3%)
Electrolyte imbalance 0/295 (0%) 1/293 (0.3%)
Fluid retention 0/295 (0%) 2/293 (0.7%)
Hypocalcaemia 0/295 (0%) 2/293 (0.7%)
Hypoglycaemia 0/295 (0%) 1/293 (0.3%)
Malnutrition 0/295 (0%) 1/293 (0.3%)
Musculoskeletal and connective tissue disorders
Arthralgia 1/295 (0.3%) 0/293 (0%)
Back pain 1/295 (0.3%) 1/293 (0.3%)
Bone disorder 0/295 (0%) 1/293 (0.3%)
Bone pain 1/295 (0.3%) 1/293 (0.3%)
Muscular weakness 1/295 (0.3%) 0/293 (0%)
Musculoskeletal pain 0/295 (0%) 1/293 (0.3%)
Myalgia 1/295 (0.3%) 2/293 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial sarcoma 1/295 (0.3%) 0/293 (0%)
Tumour haemorrhage 1/295 (0.3%) 0/293 (0%)
Metastatic pain 1/295 (0.3%) 0/293 (0%)
Nervous system disorders
Cognitive disorder 1/295 (0.3%) 0/293 (0%)
Convulsion 1/295 (0.3%) 0/293 (0%)
Epilepsy 1/295 (0.3%) 0/293 (0%)
Headache 1/295 (0.3%) 0/293 (0%)
Peripheral sensory neuropathy 0/295 (0%) 1/293 (0.3%)
Presyncope 0/295 (0%) 1/293 (0.3%)
Psychomotor skills impaired 1/295 (0.3%) 0/293 (0%)
Somnolence 1/295 (0.3%) 0/293 (0%)
Syncope 1/295 (0.3%) 1/293 (0.3%)
Tremor 1/295 (0.3%) 0/293 (0%)
Peripheral motor neuropathy 1/295 (0.3%) 1/293 (0.3%)
Psychiatric disorders
Anxiety 1/295 (0.3%) 0/293 (0%)
Confusional state 1/295 (0.3%) 0/293 (0%)
Depression 0/295 (0%) 1/293 (0.3%)
Suicide attempt 0/295 (0%) 1/293 (0.3%)
Renal and urinary disorders
Cystitis haemorrhagic 1/295 (0.3%) 0/293 (0%)
Renal failure acute 1/295 (0.3%) 0/293 (0%)
Renal impairment 1/295 (0.3%) 0/293 (0%)
Reproductive system and breast disorders
Metrorrhagia 1/295 (0.3%) 0/293 (0%)
Vaginal haemorrhage 1/295 (0.3%) 0/293 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 1/295 (0.3%) 0/293 (0%)
Dyspnoea 6/295 (2%) 5/293 (1.7%)
Epistaxis 1/295 (0.3%) 0/293 (0%)
Haemoptysis 1/295 (0.3%) 0/293 (0%)
Hydropneumothorax 1/295 (0.3%) 0/293 (0%)
Pleural effusion 5/295 (1.7%) 3/293 (1%)
Pleuritic pain 1/295 (0.3%) 0/293 (0%)
Pneumothorax 2/295 (0.7%) 0/293 (0%)
Productive cough 1/295 (0.3%) 0/293 (0%)
Pulmonary embolism 3/295 (1%) 0/293 (0%)
Respiratory failure 1/295 (0.3%) 0/293 (0%)
Skin and subcutaneous tissue disorders
Erythema 1/295 (0.3%) 0/293 (0%)
Palmar-plantar erythrodysaesthesia syndrome 4/295 (1.4%) 1/293 (0.3%)
Rash 1/295 (0.3%) 0/293 (0%)
Skin disorder 1/295 (0.3%) 0/293 (0%)
Skin toxicity 2/295 (0.7%) 0/293 (0%)
Skin ulcer 1/295 (0.3%) 0/293 (0%)
Vascular disorders
Circulatory collapse 2/295 (0.7%) 0/293 (0%)
Deep vein thrombosis 1/295 (0.3%) 1/293 (0.3%)
Embolism 1/295 (0.3%) 0/293 (0%)
Hypotension 4/295 (1.4%) 0/293 (0%)
Hypovolaemic shock 1/295 (0.3%) 0/293 (0%)
Jugular vein thrombosis 0/295 (0%) 1/293 (0.3%)
Venous thrombosis limb 1/295 (0.3%) 0/293 (0%)
Other (Not Including Serious) Adverse Events
Docetaxel + Sunitinib Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 290/295 (98.3%) 291/293 (99.3%)
Blood and lymphatic system disorders
Anaemia 67/295 (22.7%) 50/293 (17.1%)
Leukopenia 77/295 (26.1%) 83/293 (28.3%)
Neutropenia 165/295 (55.9%) 144/293 (49.1%)
Thrombocytopenia 45/295 (15.3%) 5/293 (1.7%)
Febrile neutropenia 29/295 (9.8%) 22/293 (7.5%)
Cardiac disorders
Tachycardia 21/295 (7.1%) 12/293 (4.1%)
Endocrine disorders
Hypothyroidism 17/295 (5.8%) 2/293 (0.7%)
Eye disorders
Conjunctivitis 20/295 (6.8%) 16/293 (5.5%)
Eyelid oedema 16/295 (5.4%) 2/293 (0.7%)
Lacrimation increased 69/295 (23.4%) 50/293 (17.1%)
Gastrointestinal disorders
Abdominal pain 36/295 (12.2%) 25/293 (8.5%)
Abdominal pain upper 22/295 (7.5%) 14/293 (4.8%)
Constipation 57/295 (19.3%) 51/293 (17.4%)
Diarrhoea 177/295 (60%) 111/293 (37.9%)
Dry mouth 33/295 (11.2%) 19/293 (6.5%)
Dyspepsia 70/295 (23.7%) 24/293 (8.2%)
Gastritis 18/295 (6.1%) 10/293 (3.4%)
Gingivitis 16/295 (5.4%) 2/293 (0.7%)
Nausea 119/295 (40.3%) 114/293 (38.9%)
Stomatitis 96/295 (32.5%) 75/293 (25.6%)
Vomiting 59/295 (20%) 65/293 (22.2%)
General disorders
Asthenia 99/295 (33.6%) 88/293 (30%)
Face oedema 37/295 (12.5%) 12/293 (4.1%)
Fatigue 127/295 (43.1%) 101/293 (34.5%)
Mucosal inflammation 82/295 (27.8%) 59/293 (20.1%)
Oedema 32/295 (10.8%) 16/293 (5.5%)
Oedema peripheral 67/295 (22.7%) 93/293 (31.7%)
Pyrexia 56/295 (19%) 48/293 (16.4%)
Chest pain 15/295 (5.1%) 11/293 (3.8%)
Pain 15/295 (5.1%) 12/293 (4.1%)
Infections and infestations
Infection 16/295 (5.4%) 9/293 (3.1%)
Nasopharyngitis 28/295 (9.5%) 18/293 (6.1%)
Cystitis 6/295 (2%) 16/293 (5.5%)
Investigations
Alanine aminotransferase increased 21/295 (7.1%) 10/293 (3.4%)
Aspartate aminotransferase increased 20/295 (6.8%) 10/293 (3.4%)
Haemoglobin decreased 18/295 (6.1%) 7/293 (2.4%)
Weight decreased 21/295 (7.1%) 13/293 (4.4%)
Metabolism and nutrition disorders
Decreased appetite 94/295 (31.9%) 71/293 (24.2%)
Hyperglycaemia 13/295 (4.4%) 20/293 (6.8%)
Musculoskeletal and connective tissue disorders
Arthralgia 45/295 (15.3%) 65/293 (22.2%)
Back pain 27/295 (9.2%) 31/293 (10.6%)
Bone pain 35/295 (11.9%) 38/293 (13%)
Musculoskeletal pain 26/295 (8.8%) 29/293 (9.9%)
Myalgia 53/295 (18%) 72/293 (24.6%)
Pain in extremity 40/295 (13.6%) 36/293 (12.3%)
Nervous system disorders
Dizziness 18/295 (6.1%) 15/293 (5.1%)
Dysgeusia 89/295 (30.2%) 68/293 (23.2%)
Headache 48/295 (16.3%) 38/293 (13%)
Neuropathy peripheral 41/295 (13.9%) 50/293 (17.1%)
Paraesthesia 22/295 (7.5%) 27/293 (9.2%)
Peripheral sensory neuropathy 46/295 (15.6%) 54/293 (18.4%)
Psychiatric disorders
Insomnia 29/295 (9.8%) 24/293 (8.2%)
Respiratory, thoracic and mediastinal disorders
Cough 45/295 (15.3%) 27/293 (9.2%)
Dyspnoea 63/295 (21.4%) 54/293 (18.4%)
Epistaxis 71/295 (24.1%) 16/293 (5.5%)
Oropharyngeal pain 22/295 (7.5%) 10/293 (3.4%)
Pleural effusion 20/295 (6.8%) 16/293 (5.5%)
Skin and subcutaneous tissue disorders
Alopecia 178/295 (60.3%) 188/293 (64.2%)
Dry skin 28/295 (9.5%) 15/293 (5.1%)
Erythema 28/295 (9.5%) 18/293 (6.1%)
Nail disorder 44/295 (14.9%) 61/293 (20.8%)
Onycholysis 6/295 (2%) 17/293 (5.8%)
Palmar-plantar erythrodysaesthesia syndrome 124/295 (42%) 26/293 (8.9%)
Pruritus 17/295 (5.8%) 31/293 (10.6%)
Rash 49/295 (16.6%) 50/293 (17.1%)
Skin toxicity 15/295 (5.1%) 6/293 (2%)
Vascular disorders
Flushing 14/295 (4.7%) 18/293 (6.1%)
Hypertension 36/295 (12.2%) 3/293 (1%)
Lymphoedema 14/295 (4.7%) 19/293 (6.5%)

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.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00393939
Other Study ID Numbers:
  • A6181064
First Posted:
Oct 31, 2006
Last Update Posted:
Jul 19, 2012
Last Verified:
Jul 1, 2012