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

NCT00393939 | Completed Phase 3 Results DMC

• 1 other identifier: A6181064
• Study Type: interventional
• Target: 594
• Locations: 26 countries
• Sites: 140

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.

Conditions

Breast Neoplasms

Keywords

advanced breast cancer; sunitinib; docetaxel; Phase 3

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of Participants With Objective Response

  Baseline up to Month 33

• Duration of Response (DR)

  Baseline up to Month 33

• Overall Survival (OS)

  Baseline to date of death from any cause (up to Month 33)

• 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)

• 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)

Study Arms (2)

A

EXPERIMENTAL

Drug: Sunitinib malate

B

ACTIVE COMPARATOR

Drug: Taxotere

Interventions

Sunitinib malate 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)

A

Taxotere DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
• Her-2 negative tumors

You may not qualify if:

• Patients for whom docetaxel is contraindicated
• Clinical presentation of inflammatory carcinoma with no other measurable disease

Sponsors & Collaborators

• Pfizer: lead

Study Sites (144)

Pfizer Investigational Site

Berkely, California, 94704, United States

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Shreveport, Louisiana, 71103, United States

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Beaumont, Texas, 77701, United States

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Burleson, Texas, 76028, United States

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Cleburne, Texas, 76031, United States

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Fort Worth, Texas, 76104, United States

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Mineral Wells, Texas, 76067, United States

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Weatherford, Texas, 76086, United States

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La Plata, Buenos Aires, B1902CMV, Argentina

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Pergamino, Buenos Aires, B2700CPM, Argentina

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Burnos Aires, C1426ANZ, Argentina

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Tweed Heads, New South Wales, 2485, Australia

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Redcliffe, Queensland, 4020, Australia

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Adelaide, South Australia, 5000, Australia

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Brighton, Victoria, 3186, Australia

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Malvern, Victoria, 3144, Australia

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Ringwood East, Victoria, 3135, Australia

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Perth, Western Australia, 6000, Australia

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Salzburg, A-5020, Austria

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Vienna, A-1090, Austria

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Vienna, A-1100, Austria

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Vienna, A-1160, Austria

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Brasschaat, 2930, Belgium

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Brussels, 1000, Belgium

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Verviers, 4800, Belgium

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Surrey, British Columbia, V3V 1Z2, Canada

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Greater Sudbury, Ontario, P3E 5J1, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Kingston, Ontario, K7L 5P9, Canada

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Bogota, Cundinamarca, Colombia

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Pereira, Risaralda Department, 0, Colombia

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Cali, Valle del Cauca Department, 0, Colombia

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Brno, 656 53, Czechia

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Nový Jičín, 741 01, Czechia

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Prague, 150 06, Czechia

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Prague, 180 00, Czechia

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Tampere, 33520, Finland

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Turku, 20520, Finland

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Bordeaux, 33000, France

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Dijon, 21079, France

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Nantes, 44202, France

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Reims, 51100, France

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Saint-Cloud, 92210, France

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Saint-Priest-en-Jarez, 42270, France

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Strasbourg, 67000, France

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Tours, 37000, France

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Villejuif, 94805, France

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Berlin, 12200, Germany

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Chemnitz, 09116, Germany

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Essen, 45122, Germany

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Hildesheim, 31134, Germany

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Karlsruhe, 76135, Germany

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Leverkusen, 51375, Germany

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Magdeburg, 39108, Germany

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Marburg, 35043, Germany

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Oldenburg, 26133, Germany

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Ravensburg, 88212, Germany

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Rosenheim, 83022, Germany

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Würzburg, 97080, Germany

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Budapest, 1122, Hungary

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Budapest, 1145, Hungary

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Kaposvár, 7400, Hungary

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Szentes, 6600, Hungary

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Dublin, 4, Ireland

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Dublin, 7, Ireland

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Dublin, 8, Ireland

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Galway, Ireland

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Catania, 95126, Italy

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Cattolica (RN), 47841, Italy

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Cefalu' (PA), 90015, Italy

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Chieti Scalo, 66013, Italy

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Lecce, 73100, Italy

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Livorno, 57123, Italy

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Macerata, 62100, Italy

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Napoli, 80131, Italy

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Palermo, 90146, Italy

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Pavia, 27100, Italy

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Rimini, 47900, Italy

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Roma, 00144, Italy

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Nijmegen, 6525 GA, Netherlands

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Utrecht, 3584 CX, Netherlands

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Venlo, 5912 BL, Netherlands

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Panama City, Provincia de Panamá, Panama

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Gdansk, 80-952, Poland

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Lubin, 59-300, Poland

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Poznan, 61-878, Poland

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Rybnik, 44-200, Poland

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Warsaw, 02-781, Poland

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Coimbra, 3000-075, Portugal

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Lisbon, 1099-023, Portugal

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Porto, 4200-072, Portugal

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Santa Maria da Feira, 4520-211, Portugal

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Cluj-Napoca, Cluj, 400015, Romania

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Cluj-Napoca, Cluj, 40006, Romania

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Craiova, Dolj, 200642, Romania

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Bucharest, Sector 2, 022328, Romania

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Kuzmolovo, Vsevolozhsk District, Leningradskaya Oblast', 188663, Russia

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Moscow, 115478, Russia

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Moscow, 143423, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 197758, Russia

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 812 50, Slovakia

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Bratislava, 833 10, Slovakia

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Nitra, 949 01, Slovakia

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Goyang-si, Gyeonggi-do, 410-769, South Korea

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Seoul, 120-752, South Korea

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Seoul, 138-736, South Korea

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Palma de Mallorca, Balearic Islands, 07010, Spain

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Barcelona, Barcelona, 08035, Spain

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Santiago de Compostela, La Coruña, 15706, Spain

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Madrid, Madrid, 28034, Spain

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Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

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Dos Hermanas, Sevilla, 41700, Spain

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Toledo, Toledo, 45004, Spain

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Valencia, Valencia, 46009, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46014, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Helsingborg, 251 87, Sweden

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Karlstad, 651 85, Sweden

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Stockholm, 118 83, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Ankara, 06100, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Dnipropetrovsk, 49102, Ukraine

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Donetsk, 83092, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Kyiv, 01103, Ukraine

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Kyiv, 03115, Ukraine

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Lviv, 79031, Ukraine

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Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

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Maidstone, Kent, ME16 9QQ, United Kingdom

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Manchester, M20 4bx, United Kingdom

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Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

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Shrewsbury, Shropshire, SY3 8XQ, United Kingdom

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Telford, Shropshire, TF1 6TF, United Kingdom

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Guildford, Surrey, GU2 5XX, United Kingdom

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Worthing, West Sussex, BN11 2DH, United Kingdom

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London, W6 8RF, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: October 31, 2006
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 19, 2012
• Results First Posted: February 28, 2011

Record last verified: 2012-07

Locations

ES (11); PA (1); BE (3); GB (10); HU (4); AU (7); PL (5); RO (4); TU (3); IE (4); AR (3); NL (3); CO (3); RU (5); PT (4); CA (5); SE (5); UA (6); SL (4); DE (12); FR (9); IT (12); CZ (4); FI (2); US (8); KR (3)