Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00393939
First received: October 30, 2006
Last updated: July 13, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Sunitinib malate Drug: Taxotere |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 33 ] [ Designated as safety issue: No ]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:
- Percentage of Participants With Objective Response [ Time Frame: Baseline up to Month 33 ] [ Designated as safety issue: No ]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.
- Duration of Response (DR) [ Time Frame: Baseline up to Month 33 ] [ Designated as safety issue: No ]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.
- Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to Month 33) ] [ Designated as safety issue: No ]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.
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ] [ Designated as safety issue: No ]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.
- Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ] [ Designated as safety issue: No ]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.
- Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score [ Time Frame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33) ] [ Designated as safety issue: No ]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.
| Enrollment: | 594 |
| Study Start Date: | February 2007 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393939
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| United States, California | |
| Pfizer Investigational Site | |
| Berkely, California, United States, 94704 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Beaumont, Texas, United States, 77701 | |
| Pfizer Investigational Site | |
| Burleson, Texas, United States, 76028 | |
| Pfizer Investigational Site | |
| Cleburne, Texas, United States, 76031 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
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| Mineral Wells, Texas, United States, 76067 | |
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| Weatherford, Texas, United States, 76086 | |
| Argentina | |
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| La Plata, Buenos Aires, Argentina, B1902CMV | |
| Pfizer Investigational Site | |
| Pergamino, Buenos Aires, Argentina, B2700CPM | |
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| Burnos Aires, Argentina, C1426ANZ | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Tweed Heads, New South Wales, Australia, 2485 | |
| Australia, Queensland | |
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| Redcliffe, Queensland, Australia, 4020 | |
| Australia, South Australia | |
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| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
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| Brighton, Victoria, Australia, 3186 | |
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| Malvern, Victoria, Australia, 3144 | |
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| Ringwood East, Victoria, Australia, 3135 | |
| Australia, Western Australia | |
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| Perth, Western Australia, Australia, 6000 | |
| Austria | |
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| Salzburg, Austria, A-5020 | |
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| Wien, Austria, A-1100 | |
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| Wien, Austria, A-1160 | |
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| Wien, Austria, A-1090 | |
| Belgium | |
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| Brasschaat, Belgium, 2930 | |
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| Bruxelles, Belgium, 1000 | |
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| Verviers, Belgium, 4800 | |
| Canada, British Columbia | |
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| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Canada, Ontario | |
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| Hamilton, Ontario, Canada, L8V 5C2 | |
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| Kingston, Ontario, Canada, K7L 2V7 | |
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| Kingston, Ontario, Canada, K7L 5P9 | |
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| Sudbury, Ontario, Canada, P3E 5J1 | |
| Colombia | |
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| Bogota, Cundinamarca, Colombia | |
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| Pereira, Risaralda, Colombia, 0 | |
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| Cali, Valle del Cauca, Colombia, 0 | |
| Czech Republic | |
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| Brno, Czech Republic, 656 53 | |
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| Novy Jicin, Czech Republic, 741 01 | |
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| Praha 5, Czech Republic, 150 06 | |
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| Praha 8, Czech Republic, 180 00 | |
| Finland | |
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| Tampere, Finland, 33520 | |
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| Turku, Finland, 20520 | |
| France | |
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| Bordeaux CEDEX, France, 33000 | |
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| Dijon, France, 21079 | |
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| NANTES Cedex 2, France, 44202 | |
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| Reims, France, 51100 | |
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| Saint Cloud, France, 92210 | |
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| Saint-Priest-en-Jarez Cedex, France, 42270 | |
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| Strasbourg, France, 67000 | |
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| Tours, France, 37000 | |
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| Villejuif, France, 94805 | |
| Germany | |
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| Berlin, Germany, 12200 | |
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| Chemnitz, Germany, 09116 | |
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| Essen, Germany, 45122 | |
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| Hildesheim, Germany, 31134 | |
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| Karlsruhe, Germany, 76135 | |
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| Leverkusen, Germany, 51375 | |
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| Magdeburg, Germany, 39108 | |
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| Marburg, Germany, 35043 | |
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| Oldenburg, Germany, 26133 | |
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| Ravensburg, Germany, 88212 | |
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| Rosenheim, Germany, 83022 | |
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| Wuerzburg, Germany, 97080 | |
| Hungary | |
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| Budapest, Hungary, 1145 | |
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| Budapest, Hungary, 1122 | |
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| Kaposvar, Hungary, 7400 | |
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| Szentes, Hungary, 6600 | |
| Ireland | |
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| Dublin, Ireland, 4 | |
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| Dublin, Ireland, 7 | |
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| Dublin, Ireland, 8 | |
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| Galway, Ireland | |
| Italy | |
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| Catania, Italy, 95126 | |
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| Cattolica (RN), Italy, 47841 | |
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| Cefalu' (PA), Italy, 90015 | |
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| Chieti Scalo, Italy, 66013 | |
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| Lecce, Italy, 73100 | |
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| Livorno, Italy, 57123 | |
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| Macerata, Italy, 62100 | |
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| Napoli, Italy, 80131 | |
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| Palermo, Italy, 90146 | |
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| Pavia, Italy, 27100 | |
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| Rimini, Italy, 47900 | |
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| Roma, Italy, 00144 | |
| Korea, Republic of | |
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| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
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| Seoul, Korea, Republic of, 138-736 | |
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| Seoul, Korea, Republic of, 120-752 | |
| Netherlands | |
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| Nijmegen, Netherlands, 6525 GA | |
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| Utrecht, Netherlands, 3584 CX | |
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| Venlo, Netherlands, 5912 BL | |
| Panama | |
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| Panama, Panama | |
| Poland | |
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| Gdansk, Poland, 80-952 | |
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| Lubin, Poland, 59-300 | |
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| Poznan, Poland, 61-878 | |
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| Rybnik, Poland, 44-200 | |
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| Warszawa, Poland, 02-781 | |
| Portugal | |
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| Coimbra, Portugal, 3000-075 | |
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| Lisboa, Portugal, 1099-023 | |
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| Porto, Portugal, 4200-072 | |
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| Santa Maria da Feira, Portugal, 4520-211 | |
| Romania | |
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| Cluj Napoca, Cluj, Romania, 400015 | |
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| Cluj Napoca, Cluj, Romania, 40006 | |
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| Craiova, Dolj, Romania, 200642 | |
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| Bucuresti, Sector 2, Romania, 022328 | |
| Russian Federation | |
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| Kuzmolovo, Vsevolozhsk district, Leningrad region, Russian Federation, 188663 | |
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| Moscow, Russian Federation, 115478 | |
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| Moscow, Russian Federation, 143423 | |
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| Saint Petersburg, Russian Federation, 195067 | |
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| St. Petersburg, Russian Federation, 197758 | |
| Slovakia | |
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| Banska Bystrica, Slovakia, 975 17 | |
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| Bratislava, Slovakia, 833 10 | |
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| Bratislava, Slovakia, 812 50 | |
| Pfizer Investigational Site | |
| Nitra, Slovakia, 949 01 | |
| Spain | |
| Pfizer Investigational Site | |
| Palma de Mallorca, Baleares, Spain, 07010 | |
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| Santiago de Compostela, La Coruña, Spain, 15706 | |
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| Dos Hermanas, Sevilla, Spain, 41700 | |
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| Barcelona, Spain, 08035 | |
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| Madrid, Spain, 28034 | |
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| Santa Cruz de Tenerife, Spain, 38320 | |
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| Toledo, Spain, 45004 | |
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| Valencia, Spain, 46010 | |
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| Valencia, Spain, 46009 | |
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| Valencia, Spain, 46014 | |
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| Zaragoza, Spain, 50009 | |
| Sweden | |
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| Helsingborg, Sweden, 251 87 | |
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| Karlstad, Sweden, 651 85 | |
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| Stockholm, Sweden, 118 83 | |
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| Stockholm, Sweden, 171 76 | |
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| Uppsala, Sweden, 751 85 | |
| Turkey | |
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| Ankara, Turkey, 06100 | |
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| Gaziantep, Turkey | |
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| Istanbul, Turkey | |
| Ukraine | |
| Pfizer Investigational Site | |
| Dnipropetrovsk, Ukraine, 49102 | |
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| Donetsk, Ukraine, 83092 | |
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| Ivano-Frankivsk, Ukraine, 76018 | |
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| Kyiv, Ukraine, 01103 | |
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| Kyiv, Ukraine, 03115 | |
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| Lviv, Ukraine, 79031 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Cheltenham, Gloucestershire, United Kingdom, GL53 7AN | |
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| Maidstone, Kent, United Kingdom, ME16 9QQ | |
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| Manchester, M20 4bx, United Kingdom | |
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| Wirral, Merseyside, United Kingdom, CH63 4JY | |
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| Shrewsbury, Shropshire, United Kingdom, SY3 8XQ | |
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| Telford, Shropshire, United Kingdom, TF1 6TF | |
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| Guildford, Surrey, United Kingdom, GU2 5XX | |
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| Worthing, West Sussex, United Kingdom, BN11 2DH | |
| Pfizer Investigational Site | |
| London, United Kingdom, W6 8RF | |
| Pfizer Investigational Site | |
| Wolverhampton, United Kingdom, WV10 0QP | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00393939 History of Changes |
| Other Study ID Numbers: | A6181064 |
| Study First Received: | October 30, 2006 |
| Results First Received: | January 31, 2011 |
| Last Updated: | July 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
advanced breast cancer sunitinib docetaxel Phase 3 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Docetaxel Sunitinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013