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Breast NeoplasmsPhase 3SUN 1064NCT00393939

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

A Phase 3 study testing Sunitinib malate and Taxotere in people with Breast Neoplasms, run by Pfizer at 144 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Sunitinib malate and Taxotere
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
594 participants
Where
144 sitesin 27 countries
Study dates
Feb 2007to Jul 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

144 sites in 27 countries.

144 sites in 27 countries

Germany12 sites

  • Pfizer Investigational Site

    Berlin, 12200

  • Pfizer Investigational Site

    Chemnitz, 09116

  • Pfizer Investigational Site

    Essen, 45122

  • Pfizer Investigational Site

    Hildesheim, 31134

  • Pfizer Investigational Site

    Karlsruhe, 76135

  • Pfizer Investigational Site

    Leverkusen, 51375

  • Pfizer Investigational Site

    Magdeburg, 39108

  • Pfizer Investigational Site

    Marburg, 35043

  • Pfizer Investigational Site

    Oldenburg, 26133

  • Pfizer Investigational Site

    Ravensburg, 88212

  • Pfizer Investigational Site

    Rosenheim, 83022

  • Pfizer Investigational Site

    Würzburg, 97080

Other trials in Germany

Italy12 sites

  • Pfizer Investigational Site

    Catania, 95126

  • Pfizer Investigational Site

    Cattolica (RN), 47841

  • Pfizer Investigational Site

    Cefalu' (PA), 90015

  • Pfizer Investigational Site

    Chieti Scalo, 66013

  • Pfizer Investigational Site

    Lecce, 73100

  • Pfizer Investigational Site

    Livorno, 57123

  • Pfizer Investigational Site

    Naples, 80131

  • Pfizer Investigational Site

    Palermo, 90146

  • Pfizer Investigational Site

    Pavia, 27100

  • Pfizer Investigational Site

    Province of Macerata, 62100

  • Pfizer Investigational Site

    Rimini, 47900

  • Pfizer Investigational Site

    Roma, 00144

Other trials in Italy

Spain11 sites

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08035

  • Pfizer Investigational Site

    Dos Hermanas, Sevilla, 41700

  • Pfizer Investigational Site

    Madrid, Madrid, 28034

  • Pfizer Investigational Site

    Palma de Mallorca, Balearic Islands, 07010

  • Pfizer Investigational Site

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320

  • Pfizer Investigational Site

    Santiago de Compostela, La Coruña, 15706

  • Pfizer Investigational Site

    Toledo, Toledo, 45004

  • Pfizer Investigational Site

    Valencia, Valencia, 46009

  • Pfizer Investigational Site

    Valencia, Valencia, 46010

  • Pfizer Investigational Site

    Valencia, Valencia, 46014

  • Pfizer Investigational Site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

United Kingdom10 sites

  • Pfizer Investigational Site

    Cheltenham, Gloucestershire, GL53 7AN

  • Pfizer Investigational Site

    Guildford, Surrey, GU2 5XX

  • Pfizer Investigational Site

    London, W6 8RF

  • Pfizer Investigational Site

    Maidstone, Kent, ME16 9QQ

  • Pfizer Investigational Site

    Manchester, M20 4bx

  • Pfizer Investigational Site

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY

  • Pfizer Investigational Site

    Shrewsbury, Shropshire, SY3 8XQ

  • Pfizer Investigational Site

    Telford, Shropshire, TF1 6TF

  • Pfizer Investigational Site

    Wolverhampton, WV10 0QP

  • Pfizer Investigational Site

    Worthing, West Sussex, BN11 2DH

Other trials in United Kingdom

France9 sites

  • Pfizer Investigational Site

    Bordeaux, 33000

  • Pfizer Investigational Site

    Dijon, 21079

  • Pfizer Investigational Site

    Nantes, 44202

  • Pfizer Investigational Site

    Reims, 51100

  • Pfizer Investigational Site

    Saint-Cloud, 92210

  • Pfizer Investigational Site

    Saint-Priest-en-Jarez, 42270

  • Pfizer Investigational Site

    Strasbourg, 67000

  • Pfizer Investigational Site

    Tours, 37000

  • Pfizer Investigational Site

    Villejuif, 94805

Other trials in France

United States8 sites

  • Pfizer Investigational Site

    Beaumont, Texas, 77701

  • Pfizer Investigational Site

    Berkely, California, 94704

  • Pfizer Investigational Site

    Burleson, Texas, 76028

  • Pfizer Investigational Site

    Cleburne, Texas, 76031

  • Pfizer Investigational Site

    Fort Worth, Texas, 76104

  • Pfizer Investigational Site

    Mineral Wells, Texas, 76067

  • Pfizer Investigational Site

    Shreveport, Louisiana, 71103

  • Pfizer Investigational Site

    Weatherford, Texas, 76086

Other trials in United States

Australia7 sites

  • Pfizer Investigational Site

    Adelaide, South Australia, 5000

  • Pfizer Investigational Site

    Brighton, Victoria, 3186

  • Pfizer Investigational Site

    Malvern, Victoria, 3144

  • Pfizer Investigational Site

    Perth, Western Australia, 6000

  • Pfizer Investigational Site

    Redcliffe, Queensland, 4020

  • Pfizer Investigational Site

    Ringwood East, Victoria, 3135

  • Pfizer Investigational Site

    Tweed Heads, New South Wales, 2485

Other trials in Australia

Ukraine6 sites

  • Pfizer Investigational Site

    Dnipropetrovsk, 49102

  • Pfizer Investigational Site

    Donetsk, 83092

  • Pfizer Investigational Site

    Ivano-Frankivsk, 76018

  • Pfizer Investigational Site

    Kyiv, 01103

  • Pfizer Investigational Site

    Kyiv, 03115

  • Pfizer Investigational Site

    Lviv, 79031

Other trials in Ukraine

Canada5 sites

  • Pfizer Investigational Site

    Greater Sudbury, Ontario, P3E 5J1

  • Pfizer Investigational Site

    Hamilton, Ontario, L8V 5C2

  • Pfizer Investigational Site

    Kingston, Ontario, K7L 2V7

  • Pfizer Investigational Site

    Kingston, Ontario, K7L 5P9

  • Pfizer Investigational Site

    Surrey, British Columbia, V3V 1Z2

Other trials in Canada

Poland5 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Lubin, 59-300

  • Pfizer Investigational Site

    Poznan, 61-878

  • Pfizer Investigational Site

    Rybnik, 44-200

  • Pfizer Investigational Site

    Warsaw, 02-781

Other trials in Poland

Russia5 sites

  • Pfizer Investigational Site

    Kuzmolovo, Vsevolozhsk District, Leningradskaya Oblast', 188663

  • Pfizer Investigational Site

    Moscow, 115478

  • Pfizer Investigational Site

    Moscow, 143423

  • Pfizer Investigational Site

    Saint Petersburg, 195067

  • Pfizer Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Sweden5 sites

  • Pfizer Investigational Site

    Helsingborg, 251 87

  • Pfizer Investigational Site

    Karlstad, 651 85

  • Pfizer Investigational Site

    Stockholm, 118 83

  • Pfizer Investigational Site

    Stockholm, 171 76

  • Pfizer Investigational Site

    Uppsala, 751 85

Other trials in Sweden

Austria4 sites

  • Pfizer Investigational Site

    Salzburg, A-5020

  • Pfizer Investigational Site

    Vienna, A-1090

  • Pfizer Investigational Site

    Vienna, A-1100

  • Pfizer Investigational Site

    Vienna, A-1160

Other trials in Austria

Czechia4 sites

  • Pfizer Investigational Site

    Brno, 656 53

  • Pfizer Investigational Site

    Nový Jičín, 741 01

  • Pfizer Investigational Site

    Prague, 150 06

  • Pfizer Investigational Site

    Prague, 180 00

Other trials in Czechia

Hungary4 sites

  • Pfizer Investigational Site

    Budapest, 1122

  • Pfizer Investigational Site

    Budapest, 1145

  • Pfizer Investigational Site

    Kaposvár, 7400

  • Pfizer Investigational Site

    Szentes, 6600

Other trials in Hungary

Ireland4 sites

  • Pfizer Investigational Site

    Dublin, 4

  • Pfizer Investigational Site

    Dublin, 7

  • Pfizer Investigational Site

    Dublin, 8

  • Pfizer Investigational Site

    Galway

Other trials in Ireland

Portugal4 sites

  • Pfizer Investigational Site

    Coimbra, 3000-075

  • Pfizer Investigational Site

    Lisbon, 1099-023

  • Pfizer Investigational Site

    Porto, 4200-072

  • Pfizer Investigational Site

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Romania4 sites

  • Pfizer Investigational Site

    Bucharest, Sector 2, 022328

  • Pfizer Investigational Site

    Cluj-Napoca, Cluj, 400015

  • Pfizer Investigational Site

    Cluj-Napoca, Cluj, 40006

  • Pfizer Investigational Site

    Craiova, Dolj, 200642

Other trials in Romania

Slovakia4 sites

  • Pfizer Investigational Site

    Banská Bystrica, 975 17

  • Pfizer Investigational Site

    Bratislava, 812 50

  • Pfizer Investigational Site

    Bratislava, 833 10

  • Pfizer Investigational Site

    Nitra, 949 01

Other trials in Slovakia

Argentina3 sites

  • Pfizer Investigational Site

    Burnos Aires, C1426ANZ

  • Pfizer Investigational Site

    La Plata, Buenos Aires, B1902CMV

  • Pfizer Investigational Site

    Pergamino, Buenos Aires, B2700CPM

Other trials in Argentina

Belgium3 sites

  • Pfizer Investigational Site

    Brasschaat, 2930

  • Pfizer Investigational Site

    Brussels, 1000

  • Pfizer Investigational Site

    Verviers, 4800

Other trials in Belgium

Colombia3 sites

  • Pfizer Investigational Site

    Bogota, Cundinamarca

  • Pfizer Investigational Site

    Cali, Valle del Cauca Department, 0

  • Pfizer Investigational Site

    Pereira, Risaralda Department, 0

Other trials in Colombia

Netherlands3 sites

  • Pfizer Investigational Site

    Nijmegen, 6525 GA

  • Pfizer Investigational Site

    Utrecht, 3584 CX

  • Pfizer Investigational Site

    Venlo, 5912 BL

Other trials in Netherlands

South Korea3 sites

  • Pfizer Investigational Site

    Goyang-si, Gyeonggi-do, 410-769

  • Pfizer Investigational Site

    Seoul, 120-752

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Pfizer Investigational Site

    Ankara, 06100

  • Pfizer Investigational Site

    Gaziantep

  • Pfizer Investigational Site

    Istanbul

Other trials in Turkey (Türkiye)

Finland2 sites

  • Pfizer Investigational Site

    Tampere, 33520

  • Pfizer Investigational Site

    Turku, 20520

Other trials in Finland

Panama1 site

  • Pfizer Investigational Site

    Panama City, Provincia de Panamá

Other trials in Panama

About this study

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

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.

Being tested
Sunitinib malate, Taxotere
Keywords
advanced breast cancer, sunitinib, docetaxel, Phase 3
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sunitinib malateDrug

    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)

  • TaxotereDrug

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

Study groups in NCT00393939
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Sunitinib malate
BActive comparatorNot described
Receives: Drug: Taxotere

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to Month 33

Secondary outcomes (6)

  1. 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.

    Measured: Baseline up to Month 33

  2. 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.

    Measured: Baseline up to Month 33

  3. 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.

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

  4. 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.

    Measured: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

  5. 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.

    Measured: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

  6. 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.

    Measured: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2006 (estimated)
  2. Study startFeb 2007
  3. Primary completionFeb 2010
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
594 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393939
Sponsor's protocol ID
A6181064
Acronym
SUN 1064
Status last verified
Jul 2012
First submitted
30 Oct 2006
Last updated
19 Jul 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sunitinib malate and Taxotere in people with Breast Neoplasms, run by Pfizer at 144 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in Germany, Italy, Spain, United Kingdom, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Baseline up to Month 33). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.

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