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

NCT00435409 | Completed Phase 3 Results DMC

• 1 other identifier: A6181099
• Study Type: interventional
• Target: 442
• Locations: 18 countries
• Sites: 169

Brief Summary

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Percentage of Participants With Objective Response (OR)

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

• Duration of Response (DR)

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

• Overall Survival (OS)

  Baseline until death or up to 3 years from first dose

• Percent Chance of Participant Survival

  Year 1, Year 2, Year 3

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

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

Study Arms (2)

A

EXPERIMENTAL

Drug: Sunitinib + Capecitabine

B

ACTIVE COMPARATOR

Drug: Capecitabine

Interventions

Sunitinib + Capecitabine DRUG

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.

A

Capecitabine DRUG

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.

B

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (169)

Pfizer Investigational Site

Downey, California, 90241, United States

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Fresno, California, 93720, United States

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Montebello, California, 90640, United States

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Whittier, California, 90606, United States

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Boca Raton, Florida, 33428, United States

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Boynton Beach, Florida, 33437, United States

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Coral Springs, Florida, 33065, United States

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Hollywood, Florida, 33021, United States

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Lake Worth, Florida, 33467, United States

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Lakeland, Florida, 33805, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33129, United States

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Miami, Florida, 33133, United States

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Pembroke Pines, Florida, 33028, United States

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Duluth, Georgia, 30096, United States

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Lawrenceville, Georgia, 30045, United States

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Snellville, Georgia, 30078, United States

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Avon, Indiana, 46123, United States

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Indianapolis, Indiana, 46260, United States

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Mooresville, Indiana, 46158, United States

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Covington, Louisiana, 70433, United States

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Gretna, Louisiana, 70056, United States

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Marrero, Louisiana, 70072, United States

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Metairie, Louisiana, 70002, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70115, United States

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Shreveport, Louisiana, 71103, United States

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Kensington, Maryland, 20895, United States

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Rockville, Maryland, 20850, United States

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Corinth, Mississippi, 38834, United States

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Columbia, Missouri, 65201, United States

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Billings, Montana, 59101, United States

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Albuquerque, New Mexico, 87106, United States

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Albuquerque, New Mexico, 87109, United States

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Charlotte, North Carolina, 28203, United States

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Charlotte, North Carolina, 28204, United States

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Charlotte, North Carolina, 28211, United States

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Charlotte, North Carolina, 28262, United States

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Charlotte, North Carolina, 28277, United States

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Norman, Oklahoma, 73071, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74136, United States

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Clairton, Pennsylvania, 15025, United States

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Greensburg, Pennsylvania, 15601, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Pottstown, Pennsylvania, 19464, United States

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Wexford, Pennsylvania, 15090, United States

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Franklin, Tennessee, 37067, United States

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Gallatin, Tennessee, 37066, United States

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Hermitage, Tennessee, 37076, United States

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Lebanon, Tennessee, 37087, United States

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Memphis, Tennessee, 38120, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37207, United States

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Nashville, Tennessee, 37211, United States

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Smyrna, Tennessee, 37167, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78745, United States

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Austin, Texas, 78757, United States

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Austin, Texas, 78759, United States

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Beaumont, Texas, 77701, United States

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Corpus Christi, Texas, 78405, United States

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Corpus Christi, Texas, 78410, United States

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Georgetown, Texas, 78626, United States

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Bountiful, Utah, 84010, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84157, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84106, United States

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West Provo, Utah, 84604, United States

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West Valley City, Utah, 84120, United States

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Richmond, Virginia, 23235, United States

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Richmond, Virginia, 23298-0037, United States

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Kennewick, Washington, 99336, United States

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Linz, 4010, Austria

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Salzburg, A-5020, Austria

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Wels, A-4600, Austria

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Namur, 5000, Belgium

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Turnhout, 2300, Belgium

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Yvoir, 5530, Belgium

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Calgary, Alberta, T2N 4N2, Canada

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Calgary, Alberta, T2S 3C3, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Montreal, Quebec, H3T 1M5, Canada

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Prague, 140 59, Czechia

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Prague, 150 06, Czechia

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Prague, 15006, Czechia

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Aalborg, 9100, Denmark

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Koebenhavn OE, 2100, Denmark

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Odense, 5000, Denmark

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Montpellier, Cedex 05, 34059, France

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Angers, 49033, France

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Bordeaux, 33076, France

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Caen, 14076, France

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Lyon, Cedex 08, France

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Nancy, 54100, France

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Paris, 75231, France

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Erlangen, 91054, Germany

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Frankenthal, 67227, Germany

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Frankfurt am Main, 60590, Germany

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Fürstenwalde, 15517, Germany

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Göttingen, 37099, Germany

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Münster, 48149, Germany

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Nuremberg, 90419, Germany

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Stendal, 39576, Germany

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Ulm, 89075, Germany

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Völklingen, 66333, Germany

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Heraklion, Crete, 71 110, Greece

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Athens, 18547, Greece

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Ioannina, 45 110, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 564 03, Greece

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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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Bologna, 40138, Italy

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Brescia, 25123, Italy

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Messina, 98122, Italy

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Milan, 20148, Italy

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Palermo, 90127, Italy

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Parma, 43100, Italy

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Roma, 00133, Italy

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Roma, 00144, Italy

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Saronno (VA), 21047, Italy

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Torino, 10126, Italy

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Amsterdam, 1081 HV, Netherlands

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Sittard-geleen, 6162 BG, Netherlands

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Zwolle, 8025 AB, Netherlands

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Levanger, 7600, Norway

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Oslo, 0407, Norway

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Lodz, 93-509, Poland

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Lublin, 20-090, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-781, Poland

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Cluj-Napoca, Cluj, 400015, 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, 143423, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 197758, Russia

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Barcelona, Barcelona, 08036, Spain

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Burgos, Burgos, 09005, Spain

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Cadiz, Cadiz, 11009, Spain

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A Coruña, La Coruña, 15009, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28046, Spain

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Seville, Sevilla, 41020, Spain

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Chelmsford, Essex, CM1 7WE, United Kingdom

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Harlow, Essex, CM20 1QX, United Kingdom

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Burton-on-Trent, Staffordshire, DE13 0RB, United Kingdom

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Worthing, West Sussex, BN11 2DH, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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Essex, CM16 6TN, United Kingdom

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London, W6 8RF, United Kingdom

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Swansea, SA2 8QA, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Worthing, BN11 2DH, United Kingdom

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Related Publications (1)

• 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.

  PMID: 23857972 DERIVED

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib; Capecitabine

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 15, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2011
• Last Updated: June 26, 2012
• Results First Posted: January 13, 2011

Record last verified: 2012-06

Locations

NL (3); AU (3); ES (7); CA (8); PL (4); RU (4); US (79); IT (10); NO (2); FR (7); DE (10); CZ (3); IE (3); RO (2); DK (3); BE (5); GR (5); GB (11)