A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

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NCT00471159

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
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

- Female patients with confirmed advanced breast cancer.

- Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.

- Patients with adequate general well-being, kidney and liver function.

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


- Patients that have any condition that could affect patients safety, interfere with
trial results, or makes the patient inappropriate for inclusion into study.


- Patients who have had prior chemotherapy for advanced breast cancer.


- Patients of child-bearing potential who are unwilling to use contraception.

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Breast NeoplasmsStudy Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer NCT00372996
  1. La Jolla, California
  2. La Jolla, California
  3. San Diego, California
  4. Washington, District of Columbia
  5. Davie, Florida
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  7. Lexington, Kentucky
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  9. Lexington, Kentucky
  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
  26. Houston, Texas
  27. Houston, Texas
  28. Burlington, Vermont
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  30. Burlington, Vermont
  31. Burlington, Vermont
  32. Burlington, Vermont
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  34. La Plata, Buenos Aires
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  36. La Plata, Buenos Aires
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  38. Rosario, Santa Fe
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  42. Cordoba,
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  44. Leuven,
  45. Wilrijk,
  46. Montreal, QC
  47. Santo Cristo, Rio de Janeiro
  48. Porto Alegre, Rio Grande do Sul
  49. Rio de Janeiro, RJ
  50. Porto Alegre, RS
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  52. Sao Paulo, SP
  53. Porto Alegre,
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  56. Montreal, Quebec
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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
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  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
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  52. Walnut Creek, California
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  56. Colorado Springs, Colorado
  57. Colorado Springs, Colorado
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  62. Lone Tree, Colorado
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  64. Parker, Colorado
  65. Thornton, Colorado
  66. Norwalk, Connecticut
  67. Boca Raton, Florida
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  76. Miami, Florida
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  89. Harvey, Illinois
  90. Skokie, Illinois
  91. Tinley Park, Illinois
  92. Vernon Hills, Illinois
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  94. Beech Grove, Indiana
  95. Carmel, Indiana
  96. Fishers, Indiana
  97. Greenfield, Indiana
  98. Indianapolis, Indiana
  99. Indianapolis, Indiana
  100. Indianapolis, Indiana
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  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
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  115. Baltimore, Maryland
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  117. Baltimore, Maryland
  118. Baltimore, Maryland
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  128. Kansas City, Missouri
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  136. Lincoln, Nebraska
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  149. Corning, New York
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  94. Montreal, Quebec
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  157. Madrid,
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  161. Harlow, Essex
  162. Burton upon Trent, Staffordshire
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  164. Birmingham,
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  3. Rennes, Be1 03677
  4. Brest, Be1 04292
  5. Aix en Provence,
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  7. Annecy Cedex,
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  10. Blois,
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  12. Bordeaux,
  13. Brest,
  14. Cagne sur Mer,
  15. Chalon sur Saone,
  16. Chaumont,
  17. Croix,
  18. Dijon,
  19. Douai,
  20. Draguignan,
  21. Dunkerque,
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  24. L'Union,
  25. Le Havre,
  26. Lille,
  27. Lorient,
  28. Lyon,
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  30. Marseille,
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  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,
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  51. St Cloud,
  52. St Herblain,
  53. Strasbourg,
  54. Toulon,
  55. Toulouse,
  56. Toulouse,
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
Official Title  ICMJE A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
Brief Summary To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: docetaxel
  • Drug: PF-3512676
Study Arms  ICMJE Not Provided
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 30, 2015)		0
Original Enrollment  ICMJE
 (submitted: May 7, 2007)		100
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients with confirmed advanced breast cancer.
  • Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
  • Patients with adequate general well-being, kidney and liver function.

Exclusion Criteria:

  • Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
  • Patients who have had prior chemotherapy for advanced breast cancer.
  • Patients of child-bearing potential who are unwilling to use contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471159
Other Study ID Numbers  ICMJE A8501007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015

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