A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

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NCT00373256

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Study Location
Pfizer Investigational Site
Bessemer, Alabama, 35022, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of advanced breast cancer.

- Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.

- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- No prior treatment with cytotoxics in the advanced disease setting.


- HER2/neu positive disease unless trastuzumab was previously received or is
contraindicated.


- Treatment with a taxane in the adjuvant setting unless disease free interval >12
months after end of treatment.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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  3. San Diego, California
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  5. Davie, Florida
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  7. Lexington, Kentucky
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  10. Boston, Massachusetts
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  14. Boston, Massachusetts
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  16. Minneapolis, Minnesota
  17. Minneapolis, Minnesota
  18. Minneapolis, Minnesota
  19. Burlington, North Carolina
  20. Durham, North Carolina
  21. Durham, North Carolina
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  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Dallas, Texas
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  27. Houston, Texas
  28. Burlington, Vermont
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  30. Burlington, Vermont
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  34. La Plata, Buenos Aires
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18 Years+
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MULTIPLE SITES
Breast NeoplasmsA Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer NCT00373256
  1. Bessemer, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Birmingham, Alabama
  6. Birmingham, Alabama
  7. Daphne, Alabama
  8. Mobile, Alabama
  9. Mobile, Alabama
  10. Flagstaff, Arizona
  11. Sedona, Arizona
  12. Hot Springs, Arkansas
  13. Anaheim, California
  14. Antioch, California
  15. Antioch, California
  16. Baldwin Park, California
  17. Bellflower, California
  18. Fontana, California
  19. Fountain Valley, California
  20. Gilroy, California
  21. Hawthorne, California
  22. Hayward, California
  23. Irvine, California
  24. La Jolla, California
  25. Long Beach, California
  26. Los Angeles, California
  27. Los Angeles, California
  28. Los Angeles, California
  29. Martinez, California
  30. Milpitas, California
  31. Modesto, California
  32. Mountain View, California
  33. Oakland, California
  34. Ontario, California
  35. Orange, California
  36. Oxnard, California
  37. Panorama City, California
  38. Pinole, California
  39. Riverside, California
  40. Sacramento, California
  41. San Diego, California
  42. San Diego, California
  43. San Francisco, California
  44. San Francisco, California
  45. San Francisco, California
  46. San Jose, California
  47. San Sacramento, California
  48. Santa Clara, California
  49. Santa Monica, California
  50. Union City, California
  51. Vallejo, California
  52. Walnut Creek, California
  53. Woodland Hills, California
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  55. Boulder, Colorado
  56. Colorado Springs, Colorado
  57. Colorado Springs, Colorado
  58. Denver, Colorado
  59. Denver, Colorado
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  62. Lone Tree, Colorado
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  64. Parker, Colorado
  65. Thornton, Colorado
  66. Norwalk, Connecticut
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  68. Coral Springs, Florida
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  70. Hollywood, Florida
  71. Inverness, Florida
  72. Lakeland, Florida
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  75. Miami, Florida
  76. Miami, Florida
  77. Orlando, Florida
  78. Pembroke Pines, Florida
  79. Tampa, Florida
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  82. Atlanta, Georgia
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  84. Columbus, Georgia
  85. Decatur, Georgia
  86. Macon, Georgia
  87. Marietta, Georgia
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  89. Harvey, Illinois
  90. Skokie, Illinois
  91. Tinley Park, Illinois
  92. Vernon Hills, Illinois
  93. Avon, Indiana
  94. Beech Grove, Indiana
  95. Carmel, Indiana
  96. Fishers, Indiana
  97. Greenfield, Indiana
  98. Indianapolis, Indiana
  99. Indianapolis, Indiana
  100. Indianapolis, Indiana
  101. Indianapolis, Indiana
  102. Indianapolis, Indiana
  103. Jeffersonville, Indiana
  104. Mooresville, Indiana
  105. Munster, Indiana
  106. New Albany, Indiana
  107. Kansas City, Kansas
  108. Overland Park, Kansas
  109. Louisville, Kentucky
  110. Louisville, Kentucky
  111. Louisville, Kentucky
  112. Louisville, Kentucky
  113. Louisville, Kentucky
  114. Annapolis, Maryland
  115. Baltimore, Maryland
  116. Baltimore, Maryland
  117. Baltimore, Maryland
  118. Baltimore, Maryland
  119. Columbia, Maryland
  120. Randallstown, Maryland
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  122. Peabody, Massachusetts
  123. Coon Rapids, Minnesota
  124. Robbinsdale, Minnesota
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  126. Pascagoula, Mississippi
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  128. Kansas City, Missouri
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  131. Lee's Summit, Missouri
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  136. Lincoln, Nebraska
  137. Lincoln, Nebraska
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  141. Las Vegas, Nevada
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  149. Corning, New York
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  153. Clinton, North Carolina
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  157. Kenansville, North Carolina
  158. Kinston, North Carolina
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  188. Seneca, South Carolina
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  192. Amarillo, Texas
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Breast NeoplasmsA Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer NCT00435409
  1. Downey, California
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  5. Boca Raton, Florida
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  14. Pembroke Pines, Florida
  15. Duluth, Georgia
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  17. Snellville, Georgia
  18. Avon, Indiana
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  21. Covington, Louisiana
  22. Gretna, Louisiana
  23. Marrero, Louisiana
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  25. Metairie, Louisiana
  26. New Orleans, Louisiana
  27. Shreveport, Louisiana
  28. Kensington, Maryland
  29. Rockville, Maryland
  30. Corinth, Mississippi
  31. Columbia, Missouri
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  39. Charlotte, North Carolina
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  48. Pittsburgh, Pennsylvania
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  57. Nashville, Tennessee
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  59. Nashville, Tennessee
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  67. Corpus Christi, Texas
  68. Corpus Christi, Texas
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  74. Salt Lake City, Utah
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  76. West Valley City, Utah
  77. Richmond, Virginia
  78. Richmond, Virginia
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  80. Linz,
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  84. Liege,
  85. Namur,
  86. Turnhout,
  87. Yvoir,
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  89. Calgary, Alberta
  90. Oshawa, Ontario
  91. Montreal, Quebec
  92. Montreal, Quebec
  93. Montreal, Quebec
  94. Montreal, Quebec
  95. Montreal, Quebec
  96. Praha 4,
  97. Praha 5,
  98. Praha 5,
  99. Aalborg,
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  104. BORDEAUX Cedex,
  105. CAEN Cedex 5,
  106. Lyon,
  107. Nancy,
  108. Paris,
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  110. Frankenthal,
  111. Frankfurt am Main,
  112. Fuerstenwalde,
  113. Goettingen,
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  116. Stendal,
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  120. Athens,
  121. Ioannina,
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  125. Dublin,
  126. Dublin,
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  128. Brescia,
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  130. Milano,
  131. Palermo,
  132. Parma,
  133. Roma,
  134. Roma,
  135. Saronno (VA),
  136. Torino,
  137. Amsterdam,
  138. Sittard-geleen,
  139. Zwolle,
  140. Levanger,
  141. Oslo,
  142. Lodz,
  143. Lublin,
  144. Warszawa,
  145. Warszawa,
  146. Cluj-Napoca, Cluj
  147. Bucuresti, Sector 2
  148. Kuzmolovo, Vsevolozhsk district, Leningrad region
  149. Moscow,
  150. St. Petersburg,
  151. St. Petersburg,
  152. Barcelona,
  153. Burgos,
  154. Cadiz,
  155. La Coruña,
  156. Madrid,
  157. Madrid,
  158. Sevilla,
  159. Truro, Cornwall
  160. Chelmsford, Essex
  161. Harlow, Essex
  162. Burton upon Trent, Staffordshire
  163. Worthing, West Sussex
  164. Birmingham,
  165. Essex,
  166. London,
  167. Swansea,
  168. Truro,
  169. Worthing,
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years
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  1. Marseille, Be1 01971
  2. Compiegne, Be1 02256
  3. Rennes, Be1 03677
  4. Brest, Be1 04292
  5. Aix en Provence,
  6. Amiens,
  7. Annecy Cedex,
  8. Avignon Cedex 2,
  9. Bayonne,
  10. Blois,
  11. Bordeaux CEDEX,
  12. Bordeaux,
  13. Brest,
  14. Cagne sur Mer,
  15. Chalon sur Saone,
  16. Chaumont,
  17. Croix,
  18. Dijon,
  19. Douai,
  20. Draguignan,
  21. Dunkerque,
  22. Evreux,
  23. Hyres,
  24. L'Union,
  25. Le Havre,
  26. Lille,
  27. Lorient,
  28. Lyon,
  29. Mareuil les Meaux,
  30. Marseille,
  31. Marseille,
  32. Marseille,
  33. Metz,
  34. Montauban,
  35. Montbeliard,
  36. Montelimar,
  37. Montpellier,
  38. Mougins,
  39. Nancy,
  40. Nantes Cedex 2,
  41. Neuilly,
  42. NICE Cedex 1,
  43. Nimes,
  44. Paris,
  45. Pessac,
  46. Quincy sous Senart,
  47. Reims,
  48. Ris Orangis,
  49. Saint Brieuc,
  50. Saint Nazaire,
  51. St Cloud,
  52. St Herblain,
  53. Strasbourg,
  54. Toulon,
  55. Toulouse,
  56. Toulouse,
  57. Vandoeuvre les Nancy,
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  59. Vannes,
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Official Title  ICMJE A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer
Brief Summary To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
Detailed Description On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Sunitinib
    Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
    Other Name: SU011248, Sutent
  • Drug: paclitaxel
    Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
  • Drug: bevacizumab
    Bevacizumab 10 mg/kg IV every 2 weeks.
    Other Name: Avastin
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: Sunitinib
    • Drug: paclitaxel
  • Active Comparator: B
    Interventions:
    • Drug: bevacizumab
    • Drug: paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2012)		488
Original Enrollment  ICMJE
 (submitted: September 7, 2006)		740
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of advanced breast cancer.
  • Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

  • No prior treatment with cytotoxics in the advanced disease setting.
  • HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
  • Treatment with a taxane in the adjuvant setting unless disease free interval >12 months after end of treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00373256
Other Study ID Numbers  ICMJE A6181094
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP