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

Breast Neoplasms Clinical Trial

— SUN 1064  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393939
• Other study ID #: A6181064
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2006
• Last updated: July 13, 2012
• Start date: February 2007
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: July 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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)
• Taxotere
Docetaxel 100 mg/m2 every 3 weeks in the comparator arm

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Burnos Aires
Argentina	Pfizer Investigational Site	La Plata	Buenos Aires
Argentina	Pfizer Investigational Site	Pergamino	Buenos Aires
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Brighton	Victoria
Australia	Pfizer Investigational Site	Malvern	Victoria
Australia	Pfizer Investigational Site	Perth	Western Australia
Australia	Pfizer Investigational Site	Redcliffe	Queensland
Australia	Pfizer Investigational Site	Ringwood East	Victoria
Australia	Pfizer Investigational Site	Tweed Heads	New South Wales
Austria	Pfizer Investigational Site	Salzburg
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Brasschaat
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Verviers
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Sudbury	Ontario
Canada	Pfizer Investigational Site	Surrey	British Columbia
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Cali	Valle del Cauca
Colombia	Pfizer Investigational Site	Pereira	Risaralda
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Novy Jicin
Czech Republic	Pfizer Investigational Site	Praha 5
Czech Republic	Pfizer Investigational Site	Praha 8
Finland	Pfizer Investigational Site	Tampere
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Bordeaux CEDEX
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	NANTES Cedex 2
France	Pfizer Investigational Site	Reims
France	Pfizer Investigational Site	Saint Cloud
France	Pfizer Investigational Site	Saint-Priest-en-Jarez Cedex
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Tours
France	Pfizer Investigational Site	Villejuif
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Chemnitz
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Hildesheim
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Leverkusen
Germany	Pfizer Investigational Site	Magdeburg
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Oldenburg
Germany	Pfizer Investigational Site	Ravensburg
Germany	Pfizer Investigational Site	Rosenheim
Germany	Pfizer Investigational Site	Wuerzburg
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Kaposvar
Hungary	Pfizer Investigational Site	Szentes
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Dublin
Ireland	Pfizer Investigational Site	Galway
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Cattolica (RN)
Italy	Pfizer Investigational Site	Cefalu' (PA)
Italy	Pfizer Investigational Site	Chieti Scalo
Italy	Pfizer Investigational Site	Lecce
Italy	Pfizer Investigational Site	Livorno
Italy	Pfizer Investigational Site	Macerata
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Palermo
Italy	Pfizer Investigational Site	Pavia
Italy	Pfizer Investigational Site	Rimini
Italy	Pfizer Investigational Site	Roma
Korea, Republic of	Pfizer Investigational Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Netherlands	Pfizer Investigational Site	Nijmegen
Netherlands	Pfizer Investigational Site	Utrecht
Netherlands	Pfizer Investigational Site	Venlo
Panama	Pfizer Investigational Site	Panama
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Lubin
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Rybnik
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Santa Maria da Feira
Romania	Pfizer Investigational Site	Bucuresti	Sector 2
Romania	Pfizer Investigational Site	Cluj Napoca	Cluj
Romania	Pfizer Investigational Site	Cluj Napoca	Cluj
Romania	Pfizer Investigational Site	Craiova	Dolj
Russian Federation	Pfizer Investigational Site	Kuzmolovo, Vsevolozhsk district	Leningrad region
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Nitra
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Dos Hermanas	Sevilla
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Palma de Mallorca	Baleares
Spain	Pfizer Investigational Site	Santa Cruz de Tenerife
Spain	Pfizer Investigational Site	Santiago de Compostela	La Coruña
Spain	Pfizer Investigational Site	Toledo
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Zaragoza
Sweden	Pfizer Investigational Site	Helsingborg
Sweden	Pfizer Investigational Site	Karlstad
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Uppsala
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Gaziantep
Turkey	Pfizer Investigational Site	Istanbul
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Ivano-Frankivsk
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lviv
United Kingdom	Pfizer Investigational Site	Cheltenham	Gloucestershire
United Kingdom	Pfizer Investigational Site	Guildford	Surrey
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Maidstone	Kent
United Kingdom	Pfizer Investigational Site	Manchester	M20 4bx
United Kingdom	Pfizer Investigational Site	Shrewsbury	Shropshire
United Kingdom	Pfizer Investigational Site	Telford	Shropshire
United Kingdom	Pfizer Investigational Site	Wirral	Merseyside
United Kingdom	Pfizer Investigational Site	Wolverhampton
United Kingdom	Pfizer Investigational Site	Worthing	West Sussex
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Berkely	California
United States	Pfizer Investigational Site	Burleson	Texas
United States	Pfizer Investigational Site	Cleburne	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Mineral Wells	Texas
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Weatherford	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Colombia,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Netherlands,  Panama,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	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.	Baseline up to Month 33	No
Secondary	Percentage of Participants With Objective Response	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.	Baseline up to Month 33	No
Secondary	Duration of Response (DR)	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.	Baseline up to Month 33	No
Secondary	Overall Survival (OS)	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.	Baseline to date of death from any cause (up to Month 33)	No
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score	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.	Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)	No
Secondary	Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score	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.	Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)	No
Secondary	Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score	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.	Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)	No

External Links

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