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

NCT ID: NCT00393939

Last Updated: 2012-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

594 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

advanced breast cancer sunitinib docetaxel Phase 3

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Sunitinib malate

Intervention Type DRUG

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)

B

Group Type ACTIVE_COMPARATOR

Taxotere

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

Taxotere

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Berkely, California, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Beaumont, Texas, United States

Site Status

Pfizer Investigational Site

Burleson, Texas, United States

Site Status

Pfizer Investigational Site

Cleburne, Texas, United States

Site Status

Pfizer Investigational Site

Fort Worth, Texas, United States

Site Status

Pfizer Investigational Site

Mineral Wells, Texas, United States

Site Status

Pfizer Investigational Site

Weatherford, Texas, United States

Site Status

Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Pergamino, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Burnos Aires, , Argentina

Site Status

Pfizer Investigational Site

Tweed Heads, New South Wales, Australia

Site Status

Pfizer Investigational Site

Redcliffe, Queensland, Australia

Site Status

Pfizer Investigational Site

Adelaide, South Australia, Australia

Site Status

Pfizer Investigational Site

Brighton, Victoria, Australia

Site Status

Pfizer Investigational Site

Malvern, Victoria, Australia

Site Status

Pfizer Investigational Site

Ringwood East, Victoria, Australia

Site Status

Pfizer Investigational Site

Perth, Western Australia, Australia

Site Status

Pfizer Investigational Site

Salzburg, , Austria

Site Status

Pfizer Investigational Site

Vienna, , Austria

Site Status

Pfizer Investigational Site

Vienna, , Austria

Site Status

Pfizer Investigational Site

Vienna, , Austria

Site Status

Pfizer Investigational Site

Brasschaat, , Belgium

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Verviers, , Belgium

Site Status

Pfizer Investigational Site

Surrey, British Columbia, Canada

Site Status

Pfizer Investigational Site

Greater Sudbury, Ontario, Canada

Site Status

Pfizer Investigational Site

Hamilton, Ontario, Canada

Site Status

Pfizer Investigational Site

Kingston, Ontario, Canada

Site Status

Pfizer Investigational Site

Kingston, Ontario, Canada

Site Status

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Site Status

Pfizer Investigational Site

Pereira, Risaralda Department, Colombia

Site Status

Pfizer Investigational Site

Cali, Valle del Cauca Department, Colombia

Site Status

Pfizer Investigational Site

Brno, , Czechia

Site Status

Pfizer Investigational Site

Nový Jičín, , Czechia

Site Status

Pfizer Investigational Site

Prague, , Czechia

Site Status

Pfizer Investigational Site

Prague, , Czechia

Site Status

Pfizer Investigational Site

Tampere, , Finland

Site Status

Pfizer Investigational Site

Turku, , Finland

Site Status

Pfizer Investigational Site

Bordeaux, , France

Site Status

Pfizer Investigational Site

Dijon, , France

Site Status

Pfizer Investigational Site

Nantes, , France

Site Status

Pfizer Investigational Site

Reims, , France

Site Status

Pfizer Investigational Site

Saint-Cloud, , France

Site Status

Pfizer Investigational Site

Saint-Priest-en-Jarez, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Tours, , France

Site Status

Pfizer Investigational Site

Villejuif, , France

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Chemnitz, , Germany

Site Status

Pfizer Investigational Site

Essen, , Germany

Site Status

Pfizer Investigational Site

Hildesheim, , Germany

Site Status

Pfizer Investigational Site

Karlsruhe, , Germany

Site Status

Pfizer Investigational Site

Leverkusen, , Germany

Site Status

Pfizer Investigational Site

Magdeburg, , Germany

Site Status

Pfizer Investigational Site

Marburg, , Germany

Site Status

Pfizer Investigational Site

Oldenburg, , Germany

Site Status

Pfizer Investigational Site

Ravensburg, , Germany

Site Status

Pfizer Investigational Site

Rosenheim, , Germany

Site Status

Pfizer Investigational Site

Würzburg, , Germany

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Kaposvár, , Hungary

Site Status

Pfizer Investigational Site

Szentes, , Hungary

Site Status

Pfizer Investigational Site

Dublin, , Ireland

Site Status

Pfizer Investigational Site

Dublin, , Ireland

Site Status

Pfizer Investigational Site

Dublin, , Ireland

Site Status

Pfizer Investigational Site

Galway, , Ireland

Site Status

Pfizer Investigational Site

Catania, , Italy

Site Status

Pfizer Investigational Site

Cattolica (RN), , Italy

Site Status

Pfizer Investigational Site

Cefalu' (PA), , Italy

Site Status

Pfizer Investigational Site

Chieti Scalo, , Italy

Site Status

Pfizer Investigational Site

Lecce, , Italy

Site Status

Pfizer Investigational Site

Livorno, , Italy

Site Status

Pfizer Investigational Site

Macerata, , Italy

Site Status

Pfizer Investigational Site

Napoli, , Italy

Site Status

Pfizer Investigational Site

Palermo, , Italy

Site Status

Pfizer Investigational Site

Pavia, , Italy

Site Status

Pfizer Investigational Site

Rimini, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Nijmegen, , Netherlands

Site Status

Pfizer Investigational Site

Utrecht, , Netherlands

Site Status

Pfizer Investigational Site

Venlo, , Netherlands

Site Status

Pfizer Investigational Site

Panama City, Provincia de Panamá, Panama

Site Status

Pfizer Investigational Site

Gdansk, , Poland

Site Status

Pfizer Investigational Site

Lubin, , Poland

Site Status

Pfizer Investigational Site

Poznan, , Poland

Site Status

Pfizer Investigational Site

Rybnik, , Poland

Site Status

Pfizer Investigational Site

Warsaw, , Poland

Site Status

Pfizer Investigational Site

Coimbra, , Portugal

Site Status

Pfizer Investigational Site

Lisbon, , Portugal

Site Status

Pfizer Investigational Site

Porto, , Portugal

Site Status

Pfizer Investigational Site

Santa Maria da Feira, , Portugal

Site Status

Pfizer Investigational Site

Cluj-Napoca, Cluj, Romania

Site Status

Pfizer Investigational Site

Cluj-Napoca, Cluj, Romania

Site Status

Pfizer Investigational Site

Craiova, Dolj, Romania

Site Status

Pfizer Investigational Site

Bucharest, Sector 2, Romania

Site Status

Pfizer Investigational Site

Kuzmolovo, Vsevolozhsk District, Leningradskaya Oblast', Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Banská Bystrica, , Slovakia

Site Status

Pfizer Investigational Site

Bratislava, , Slovakia

Site Status

Pfizer Investigational Site

Bratislava, , Slovakia

Site Status

Pfizer Investigational Site

Nitra, , Slovakia

Site Status

Pfizer Investigational Site

Goyang-si, Gyeonggi-do, South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Palma de Mallorca, Balearic Islands, Spain

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Santiago de Compostela, La Coruña, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Site Status

Pfizer Investigational Site

Dos Hermanas, Sevilla, Spain

Site Status

Pfizer Investigational Site

Toledo, Toledo, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Pfizer Investigational Site

Zaragoza, Zaragoza, Spain

Site Status

Pfizer Investigational Site

Helsingborg, , Sweden

Site Status

Pfizer Investigational Site

Karlstad, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Uppsala, , Sweden

Site Status

Pfizer Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Gaziantep, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

Pfizer Investigational Site

Donetsk, , Ukraine

Site Status

Pfizer Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

Pfizer Investigational Site

Kyiv, , Ukraine

Site Status

Pfizer Investigational Site

Kyiv, , Ukraine

Site Status

Pfizer Investigational Site

Lviv, , Ukraine

Site Status

Pfizer Investigational Site

Cheltenham, Gloucestershire, United Kingdom

Site Status

Pfizer Investigational Site

Maidstone, Kent, United Kingdom

Site Status

Pfizer Investigational Site

Manchester, M20 4bx, United Kingdom

Site Status

Pfizer Investigational Site

Metropolitan Borough of Wirral, Merseyside, United Kingdom

Site Status

Pfizer Investigational Site

Shrewsbury, Shropshire, United Kingdom

Site Status

Pfizer Investigational Site

Telford, Shropshire, United Kingdom

Site Status

Pfizer Investigational Site

Guildford, Surrey, United Kingdom

Site Status

Pfizer Investigational Site

Worthing, West Sussex, United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Wolverhampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Canada Colombia Czechia Finland France Germany Hungary Ireland Italy Netherlands Panama Poland Portugal Romania Russia Slovakia South Korea Spain Sweden Turkey (Türkiye) Ukraine United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6181064

Identifier Type: -

Identifier Source: org_study_id