Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00393939




Registration number
NCT00393939
Ethics application status
Date submitted
30/10/2006
Date registered
31/10/2006
Date last updated
19/07/2012

Titles & IDs
Public title
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Scientific title
A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
Secondary ID [1] 0 0
A6181064
Universal Trial Number (UTN)
Trial acronym
SUN 1064
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sunitinib malate
Treatment: Drugs - Taxotere

Experimental: A -

Active comparator: B -


Treatment: Drugs: 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)

Treatment: Drugs: Taxotere
Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Baseline up to Month 33
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response
Timepoint [1] 0 0
Baseline up to Month 33
Secondary outcome [2] 0 0
Duration of Response (DR)
Timepoint [2] 0 0
Baseline up to Month 33
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to date of death from any cause (up to Month 33)
Secondary outcome [4] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
Timepoint [4] 0 0
Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
Secondary outcome [5] 0 0
Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score
Timepoint [5] 0 0
Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
Secondary outcome [6] 0 0
Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score
Timepoint [6] 0 0
Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

Eligibility
Key inclusion criteria
* Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
* Her-2 negative tumors
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients for whom docetaxel is contraindicated
* Clinical presentation of inflammatory carcinoma with no other measurable disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
594
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Tweed Heads
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Redcliffe
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Brighton
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Malvern
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Ringwood East
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
4020 - Redcliffe
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3186 - Brighton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
3135 - Ringwood East
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Burnos Aires
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Belgium
State/province [8] 0 0
Brasschaat
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Verviers
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Colombia
State/province [13] 0 0
Cundinamarca
Country [14] 0 0
Colombia
State/province [14] 0 0
Risaralda
Country [15] 0 0
Colombia
State/province [15] 0 0
Valle del Cauca
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Brno
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Novy Jicin
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha 5
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Praha 8
Country [20] 0 0
Finland
State/province [20] 0 0
Tampere
Country [21] 0 0
Finland
State/province [21] 0 0
Turku
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux CEDEX
Country [23] 0 0
France
State/province [23] 0 0
Dijon
Country [24] 0 0
France
State/province [24] 0 0
NANTES Cedex 2
Country [25] 0 0
France
State/province [25] 0 0
Reims
Country [26] 0 0
France
State/province [26] 0 0
Saint Cloud
Country [27] 0 0
France
State/province [27] 0 0
Saint-Priest-en-Jarez Cedex
Country [28] 0 0
France
State/province [28] 0 0
Strasbourg
Country [29] 0 0
France
State/province [29] 0 0
Tours
Country [30] 0 0
France
State/province [30] 0 0
Villejuif
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Chemnitz
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Hildesheim
Country [35] 0 0
Germany
State/province [35] 0 0
Karlsruhe
Country [36] 0 0
Germany
State/province [36] 0 0
Leverkusen
Country [37] 0 0
Germany
State/province [37] 0 0
Magdeburg
Country [38] 0 0
Germany
State/province [38] 0 0
Marburg
Country [39] 0 0
Germany
State/province [39] 0 0
Oldenburg
Country [40] 0 0
Germany
State/province [40] 0 0
Ravensburg
Country [41] 0 0
Germany
State/province [41] 0 0
Rosenheim
Country [42] 0 0
Germany
State/province [42] 0 0
Wuerzburg
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Kaposvar
Country [45] 0 0
Hungary
State/province [45] 0 0
Szentes
Country [46] 0 0
Ireland
State/province [46] 0 0
Dublin
Country [47] 0 0
Ireland
State/province [47] 0 0
Galway
Country [48] 0 0
Italy
State/province [48] 0 0
Catania
Country [49] 0 0
Italy
State/province [49] 0 0
Cattolica (RN)
Country [50] 0 0
Italy
State/province [50] 0 0
Cefalu' (PA)
Country [51] 0 0
Italy
State/province [51] 0 0
Chieti Scalo
Country [52] 0 0
Italy
State/province [52] 0 0
Lecce
Country [53] 0 0
Italy
State/province [53] 0 0
Livorno
Country [54] 0 0
Italy
State/province [54] 0 0
Macerata
Country [55] 0 0
Italy
State/province [55] 0 0
Napoli
Country [56] 0 0
Italy
State/province [56] 0 0
Palermo
Country [57] 0 0
Italy
State/province [57] 0 0
Pavia
Country [58] 0 0
Italy
State/province [58] 0 0
Rimini
Country [59] 0 0
Italy
State/province [59] 0 0
Roma
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Gyeonggi-do
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seoul
Country [62] 0 0
Netherlands
State/province [62] 0 0
Nijmegen
Country [63] 0 0
Netherlands
State/province [63] 0 0
Utrecht
Country [64] 0 0
Netherlands
State/province [64] 0 0
Venlo
Country [65] 0 0
Panama
State/province [65] 0 0
Panama
Country [66] 0 0
Poland
State/province [66] 0 0
Gdansk
Country [67] 0 0
Poland
State/province [67] 0 0
Lubin
Country [68] 0 0
Poland
State/province [68] 0 0
Poznan
Country [69] 0 0
Poland
State/province [69] 0 0
Rybnik
Country [70] 0 0
Poland
State/province [70] 0 0
Warszawa
Country [71] 0 0
Portugal
State/province [71] 0 0
Coimbra
Country [72] 0 0
Portugal
State/province [72] 0 0
Lisboa
Country [73] 0 0
Portugal
State/province [73] 0 0
Porto
Country [74] 0 0
Portugal
State/province [74] 0 0
Santa Maria da Feira
Country [75] 0 0
Romania
State/province [75] 0 0
Cluj
Country [76] 0 0
Romania
State/province [76] 0 0
Dolj
Country [77] 0 0
Romania
State/province [77] 0 0
Sector 2
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Leningrad region
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Saint Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
St. Petersburg
Country [82] 0 0
Slovakia
State/province [82] 0 0
Banska Bystrica
Country [83] 0 0
Slovakia
State/province [83] 0 0
Bratislava
Country [84] 0 0
Slovakia
State/province [84] 0 0
Nitra
Country [85] 0 0
Spain
State/province [85] 0 0
Baleares
Country [86] 0 0
Spain
State/province [86] 0 0
La Coruña
Country [87] 0 0
Spain
State/province [87] 0 0
Sevilla
Country [88] 0 0
Spain
State/province [88] 0 0
Barcelona
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Spain
State/province [90] 0 0
Santa Cruz de Tenerife
Country [91] 0 0
Spain
State/province [91] 0 0
Toledo
Country [92] 0 0
Spain
State/province [92] 0 0
Valencia
Country [93] 0 0
Spain
State/province [93] 0 0
Zaragoza
Country [94] 0 0
Sweden
State/province [94] 0 0
Helsingborg
Country [95] 0 0
Sweden
State/province [95] 0 0
Karlstad
Country [96] 0 0
Sweden
State/province [96] 0 0
Stockholm
Country [97] 0 0
Sweden
State/province [97] 0 0
Uppsala
Country [98] 0 0
Turkey
State/province [98] 0 0
Ankara
Country [99] 0 0
Turkey
State/province [99] 0 0
Gaziantep
Country [100] 0 0
Turkey
State/province [100] 0 0
Istanbul
Country [101] 0 0
Ukraine
State/province [101] 0 0
Dnipropetrovsk
Country [102] 0 0
Ukraine
State/province [102] 0 0
Donetsk
Country [103] 0 0
Ukraine
State/province [103] 0 0
Ivano-Frankivsk
Country [104] 0 0
Ukraine
State/province [104] 0 0
Kyiv
Country [105] 0 0
Ukraine
State/province [105] 0 0
Lviv
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Gloucestershire
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Kent
Country [108] 0 0
United Kingdom
State/province [108] 0 0
M20 4bx
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Merseyside
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Shropshire
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Surrey
Country [112] 0 0
United Kingdom
State/province [112] 0 0
West Sussex
Country [113] 0 0
United Kingdom
State/province [113] 0 0
London
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00393939