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Breast NeoplasmsPhase 3NCT00435409

A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

A Phase 3 study testing Sunitinib + Capecitabine and Capecitabine in people with Breast Neoplasms, run by Pfizer at 169 sites in 18 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

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Sunitinib + Capecitabine and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
442 participants
Where
169 sitesin 18 countries
Study dates
Feb 2007to Jun 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
  • Previous treatment with an anthracycline and a taxane in any setting
  • Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Who cannot join

  • History of inflammatory carcinoma if there is no other measurable disease
  • More than 2 chemotherapy agents in the advanced disease setting
  • Brain metastases

Trial locations and contacts

169 sites in 18 countries.

169 sites in 18 countries

United States79 sites

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87106

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87109

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Austin, Texas, 78745

  • Pfizer Investigational Site

    Austin, Texas, 78757

  • Pfizer Investigational Site

    Austin, Texas, 78759

  • Pfizer Investigational Site

    Avon, Indiana, 46123

  • Pfizer Investigational Site

    Beaumont, Texas, 77701

  • Pfizer Investigational Site

    Billings, Montana, 59101

  • Pfizer Investigational Site

    Boca Raton, Florida, 33428

  • Pfizer Investigational Site

    Bountiful, Utah, 84010

  • Pfizer Investigational Site

    Boynton Beach, Florida, 33437

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28203

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28204

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28211

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28262

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28277

  • Pfizer Investigational Site

    Clairton, Pennsylvania, 15025

  • Pfizer Investigational Site

    Columbia, Missouri, 65201

  • Pfizer Investigational Site

    Coral Springs, Florida, 33065

  • Pfizer Investigational Site

    Corinth, Mississippi, 38834

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78405

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78410

  • Pfizer Investigational Site

    Covington, Louisiana, 70433

  • Pfizer Investigational Site

    Downey, California, 90241

  • Pfizer Investigational Site

    Duluth, Georgia, 30096

  • Pfizer Investigational Site

    Franklin, Tennessee, 37067

  • Pfizer Investigational Site

    Fresno, California, 93720

  • Pfizer Investigational Site

    Gallatin, Tennessee, 37066

  • Pfizer Investigational Site

    Georgetown, Texas, 78626

  • Pfizer Investigational Site

    Greensburg, Pennsylvania, 15601

  • Pfizer Investigational Site

    Gretna, Louisiana, 70056

  • Pfizer Investigational Site

    Hermitage, Tennessee, 37076

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46260

  • Pfizer Investigational Site

    Kennewick, Washington, 99336

  • Pfizer Investigational Site

    Kensington, Maryland, 20895

  • Pfizer Investigational Site

    Lake Worth, Florida, 33467

  • Pfizer Investigational Site

    Lakeland, Florida, 33805

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30045

  • Pfizer Investigational Site

    Layton, Utah, 84041

  • Pfizer Investigational Site

    Lebanon, Tennessee, 37087

  • Pfizer Investigational Site

    Marrero, Louisiana, 70072

  • Pfizer Investigational Site

    Memphis, Tennessee, 38120

  • Pfizer Investigational Site

    Metairie, Louisiana, 70002

  • Pfizer Investigational Site

    Metairie, Louisiana, 70006

  • Pfizer Investigational Site

    Miami, Florida, 33125

  • Pfizer Investigational Site

    Miami, Florida, 33129

  • Pfizer Investigational Site

    Miami, Florida, 33133

  • Pfizer Investigational Site

    Montebello, California, 90640

  • Pfizer Investigational Site

    Mooresville, Indiana, 46158

  • Pfizer Investigational Site

    Murfreesboro, Tennessee, 37130

  • Pfizer Investigational Site

    Murray, Utah, 84157

  • Pfizer Investigational Site

    Nashville, Tennessee, 37203

  • Pfizer Investigational Site

    Nashville, Tennessee, 37205

  • Pfizer Investigational Site

    Nashville, Tennessee, 37207

  • Pfizer Investigational Site

    Nashville, Tennessee, 37211

  • Pfizer Investigational Site

    New Orleans, Louisiana, 70115

  • Pfizer Investigational Site

    Norman, Oklahoma, 73071

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73120

  • Pfizer Investigational Site

    Pembroke Pines, Florida, 33028

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • Pfizer Investigational Site

    Pottstown, Pennsylvania, 19464

  • Pfizer Investigational Site

    Richmond, Virginia, 23235

  • Pfizer Investigational Site

    Richmond, Virginia, 23298-0037

  • Pfizer Investigational Site

    Rockville, Maryland, 20850

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84102

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84106

  • Pfizer Investigational Site

    Shreveport, Louisiana, 71103

  • Pfizer Investigational Site

    Smyrna, Tennessee, 37167

  • Pfizer Investigational Site

    Snellville, Georgia, 30078

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74133

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74136

  • Pfizer Investigational Site

    West Provo, Utah, 84604

  • Pfizer Investigational Site

    West Valley City, Utah, 84120

  • Pfizer Investigational Site

    Wexford, Pennsylvania, 15090

  • Pfizer Investigational Site

    Whittier, California, 90606

Other trials in United States

United Kingdom11 sites

  • Pfizer Investigational Site

    Birmingham, B15 2TH

  • Pfizer Investigational Site

    Burton-on-Trent, Staffordshire, DE13 0RB

  • Pfizer Investigational Site

    Chelmsford, Essex, CM1 7WE

  • Pfizer Investigational Site

    Essex, CM16 6TN

  • Pfizer Investigational Site

    Harlow, Essex, CM20 1QX

  • Pfizer Investigational Site

    London, W6 8RF

  • Pfizer Investigational Site

    Swansea, SA2 8QA

  • Pfizer Investigational Site

    Truro, Cornwall, TR1 3LJ

  • Pfizer Investigational Site

    Truro, TR1 3LJ

  • Pfizer Investigational Site

    Worthing, West Sussex, BN11 2DH

  • Pfizer Investigational Site

    Worthing, BN11 2DH

Other trials in United Kingdom

Germany10 sites

  • Pfizer Investigational Site

    Erlangen, 91054

  • Pfizer Investigational Site

    Frankenthal, 67227

  • Pfizer Investigational Site

    Frankfurt am Main, 60590

  • Pfizer Investigational Site

    Fürstenwalde, 15517

  • Pfizer Investigational Site

    Göttingen, 37099

  • Pfizer Investigational Site

    Münster, 48149

  • Pfizer Investigational Site

    Nuremberg, 90419

  • Pfizer Investigational Site

    Stendal, 39576

  • Pfizer Investigational Site

    Ulm, 89075

  • Pfizer Investigational Site

    Völklingen, 66333

Other trials in Germany

Italy10 sites

  • Pfizer Investigational Site

    Bologna, 40138

  • Pfizer Investigational Site

    Brescia, 25123

  • Pfizer Investigational Site

    Messina, 98122

  • Pfizer Investigational Site

    Milan, 20148

  • Pfizer Investigational Site

    Palermo, 90127

  • Pfizer Investigational Site

    Parma, 43100

  • Pfizer Investigational Site

    Roma, 00133

  • Pfizer Investigational Site

    Roma, 00144

  • Pfizer Investigational Site

    Saronno (VA), 21047

  • Pfizer Investigational Site

    Torino, 10126

Other trials in Italy

Canada8 sites

  • Pfizer Investigational Site

    Calgary, Alberta, T2N 4N2

  • Pfizer Investigational Site

    Calgary, Alberta, T2S 3C3

  • Pfizer Investigational Site

    Montreal, Quebec, H2W 1T8

  • Pfizer Investigational Site

    Montreal, Quebec, H3A 1A1

  • Pfizer Investigational Site

    Montreal, Quebec, H3G 1A4

  • Pfizer Investigational Site

    Montreal, Quebec, H3T 1E2

  • Pfizer Investigational Site

    Montreal, Quebec, H3T 1M5

  • Pfizer Investigational Site

    Oshawa, Ontario, L1G 2B9

Other trials in Canada

France7 sites

  • Pfizer Investigational Site

    Angers, 49033

  • Pfizer Investigational Site

    Bordeaux, 33076

  • Pfizer Investigational Site

    Caen, 14076

  • Pfizer Investigational Site

    Lyon, Cedex 08

  • Pfizer Investigational Site

    Montpellier, Cedex 05, 34059

  • Pfizer Investigational Site

    Nancy, 54100

  • Pfizer Investigational Site

    Paris, 75231

Other trials in France

Spain7 sites

  • Pfizer Investigational Site

    A Coruña, La Coruña, 15009

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08036

  • Pfizer Investigational Site

    Burgos, Burgos, 09005

  • Pfizer Investigational Site

    Cadiz, Cadiz, 11009

  • Pfizer Investigational Site

    Madrid, Madrid, 28034

  • Pfizer Investigational Site

    Madrid, Madrid, 28046

  • Pfizer Investigational Site

    Seville, Sevilla, 41020

Other trials in Spain

Belgium5 sites

  • Pfizer Investigational Site

    Leuven, 3000

  • Pfizer Investigational Site

    Liège, 4000

  • Pfizer Investigational Site

    Namur, 5000

  • Pfizer Investigational Site

    Turnhout, 2300

  • Pfizer Investigational Site

    Yvoir, 5530

Other trials in Belgium

Greece5 sites

  • Pfizer Investigational Site

    Athens, 18547

  • Pfizer Investigational Site

    Heraklion, Crete, 71 110

  • Pfizer Investigational Site

    Ioannina, 45 110

  • Pfizer Investigational Site

    Pátrai, 26500

  • Pfizer Investigational Site

    Thessaloniki, 564 03

Other trials in Greece

Poland4 sites

  • Pfizer Investigational Site

    Lodz, 93-509

  • Pfizer Investigational Site

    Lublin, 20-090

  • Pfizer Investigational Site

    Warsaw, 00-909

  • Pfizer Investigational Site

    Warsaw, 02-781

Other trials in Poland

Russia4 sites

  • Pfizer Investigational Site

    Kuzmolovo, Vsevolozhsk District, Leningradskaya Oblast', 188663

  • Pfizer Investigational Site

    Moscow, 143423

  • Pfizer Investigational Site

    Saint Petersburg, 191104

  • Pfizer Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Austria3 sites

  • Pfizer Investigational Site

    Linz, 4010

  • Pfizer Investigational Site

    Salzburg, A-5020

  • Pfizer Investigational Site

    Wels, A-4600

Other trials in Austria

Czechia3 sites

  • Pfizer Investigational Site

    Prague, 140 59

  • Pfizer Investigational Site

    Prague, 150 06

  • Pfizer Investigational Site

    Prague, 15006

Other trials in Czechia

Denmark3 sites

  • Pfizer Investigational Site

    Aalborg, 9100

  • Pfizer Investigational Site

    Koebenhavn OE, 2100

  • Pfizer Investigational Site

    Odense, 5000

Other trials in Denmark

Ireland3 sites

  • Pfizer Investigational Site

    Dublin, 4

  • Pfizer Investigational Site

    Dublin, 7

  • Pfizer Investigational Site

    Dublin, 8

Other trials in Ireland

Netherlands3 sites

  • Pfizer Investigational Site

    Amsterdam, 1081 HV

  • Pfizer Investigational Site

    Sittard-geleen, 6162 BG

  • Pfizer Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Norway2 sites

  • Pfizer Investigational Site

    Levanger, 7600

  • Pfizer Investigational Site

    Oslo, 0407

Other trials in Norway

Romania2 sites

  • Pfizer Investigational Site

    Bucharest, Sector 2, 022328

  • Pfizer Investigational Site

    Cluj-Napoca, Cluj, 400015

Other trials in Romania

About this study

Official title: A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

Being tested
Sunitinib + Capecitabine, Capecitabine
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 + CapecitabineDrug

    Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen.

    Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.

  • CapecitabineDrug

    Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day [1250 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

Study groups in NCT00435409
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Sunitinib + Capecitabine
BActive comparatorNot described
Receives: Drug: Capecitabine

What is being measured

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

  1. Progression Free Survival (PFS)

    Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.

    Measured: Baseline until disease progression (up to 3 years from first dose)

Secondary outcomes (7)

  1. Percentage of Participants With Objective Response (OR)

    Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.

    Measured: Baseline until response or disease progression (up to 3 years from first dose)

  2. Duration of Response (DR)

    Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.

    Measured: Baseline until response or disease progression (up to 3 years from first dose)

  3. Overall Survival (OS)

    Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.

    Measured: Baseline until death or up to 3 years from first dose

  4. Percent Chance of Participant Survival

    Probability of survival 2 years and 3 years after the first dose of study treatment.

    Measured: Year 1, Year 2, Year 3

  5. Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms

    Measured: Day 1 of each treatment cycle (up to 3 years or end of treatment)

  6. Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)

    BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

    Measured: Day 1 of each treatment cycle (up to 3 years or end of treatment)

  7. Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)

    EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.

    Measured: Day 1 of each treatment cycle (up to 3 years or end of treatment)

Timeline

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

  1. First posted15 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionDec 2009
  4. Study completionJun 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
Crossover
Masking
None (open label)
Enrolment
442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00435409
Sponsor's protocol ID
A6181099
Status last verified
Jun 2012
First submitted
13 Feb 2007
Last updated
26 Jun 2012
Data monitoring committee
Yes

Publications

  • Crown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.

    PubMed 23857972

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sunitinib + Capecitabine and Capecitabine in people with Breast Neoplasms, run by Pfizer at 169 sites in 18 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 3 inclusion and 3 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 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, United Kingdom, Germany, Italy, Canada and 13 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 13 Jan 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 until disease progression (up to 3 years from first dose)). 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 NCT00435409, which also lists 1 linked publication.

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 26 Jun 2012.

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