Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Back to Search
Print
Bookmark Trial

NCT02679755

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Alexander David Guminski
North Sydney, New South Wales, 2060, Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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]

Call Now

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

- Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Adequate bone marrow, liver, and renal function.

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


- Prior treatment with any CDK inhibitor .


- QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc
prolongation, or Torsade de Pointes.


- High cardiovascular risk, including, but not limited to myocardial infarction,
severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary
embolism in the past 6 months of enrollment.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Breast CancerNeoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -
NCT03819010
  1. Badalona, Barcelona
  2. Madrid,
  3. Valencia,
  4. Oporto,
Female
18 Years+
years
MULTIPLE SITES
Breast CancerExemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
NCT00201773
  1. Columbus, Ohio
Female
18 Years+
years
MULTIPLE SITES
Breast CancerPALbociclib CoLlaborative Adjuvant Study
NCT02513394
  1. Mobile, Alabama
  2. Mobile, Alabama
  3. Anchorage, Alaska
  4. Anchorage, Alaska
  5. Phoenix, Arizona
  6. Greenbrae, California
  7. Greenbrae, California
  8. La Jolla, California
  9. Los Angeles, California
  10. Oakland, California
  11. Palo Alto, California
  12. Roseville, California
  13. Sacramento, California
  14. San Diego, California
  15. San Diego, California
  16. San Diego, California
  17. San Francisco, California
  18. San Francisco, California
  19. San Leandro, California
  20. Santa Clara, California
  21. South San Francisco, California
  22. Stanford, California
  23. Vallejo, California
  24. Walnut Creek, California
  25. Denver, Colorado
  26. Hartford, Connecticut
  27. New Britain, Connecticut
  28. Newark, Delaware
  29. Washington, District of Columbia
  30. Washington, District of Columbia
  31. Clearwater, Florida
  32. Jacksonville, Florida
  33. Miami Beach, Florida
  34. Miami, Florida
  35. Orlando, Florida
  36. Atlanta, Georgia
  37. Chicago, Illinois
  38. Chicago, Illinois
  39. Chicago, Illinois
  40. Decatur, Illinois
  41. Harvey, Illinois
  42. Joliet, Illinois
  43. Park Ridge, Illinois
  44. Peoria, Illinois
  45. Rockford, Illinois
  46. Skokie, Illinois
  47. Skokie, Illinois
  48. Urbana, Illinois
  49. Indianapolis, Indiana
  50. Muncie, Indiana
  51. Ames, Iowa
  52. Ames, Iowa
  53. Cedar Rapids, Iowa
  54. Des Moines, Iowa
  55. Waterloo, Iowa
  56. Lexington, Kentucky
  57. Louisville, Kentucky
  58. New Orleans, Louisiana
  59. Bangor, Maine
  60. Scarborough, Maine
  61. Annapolis, Maryland
  62. Baltimore, Maryland
  63. Baltimore, Maryland
  64. Baltimore, Maryland
  65. Baltimore, Maryland
  66. Baltimore, Maryland
  67. Baltimore, Maryland
  68. Bethesda, Maryland
  69. Salisbury, Maryland
  70. Silver Spring, Maryland
  71. Boston, Massachusetts
  72. Boston, Massachusetts
  73. Boston, Massachusetts
  74. Boston, Massachusetts
  75. Lowell, Massachusetts
  76. Plymouth, Massachusetts
  77. Ann Arbor, Michigan
  78. Grand Rapids, Michigan
  79. Livonia, Michigan
  80. Duluth, Minnesota
  81. Rochester, Minnesota
  82. Rochester, Minnesota
  83. Saint Cloud, Minnesota
  84. Saint Louis Park, Minnesota
  85. Saint Louis Park, Minnesota
  86. Kansas City, Missouri
  87. Rolla, Missouri
  88. Saint Louis, Missouri
  89. Saint Louis, Missouri
  90. Saint Louis, Missouri
  91. Springfield, Missouri
  92. Omaha, Nebraska
  93. Concord, New Hampshire
  94. Hooksett, New Hampshire
  95. Lebanon, New Hampshire
  96. Lebanon, New Hampshire
  97. Englewood, New Jersey
  98. Hackensack, New Jersey
  99. Albuquerque, New Mexico
  100. Albuquerque, New Mexico
  101. Bronx, New York
  102. Buffalo, New York
  103. East Syracuse, New York
  104. Jamaica, New York
  105. New Hyde Park, New York
  106. New York, New York
  107. New York, New York
  108. New York, New York
  109. Oneonta, New York
  110. Syracuse, New York
  111. Charlotte, North Carolina
  112. Durham, North Carolina
  113. Greensboro, North Carolina
  114. Pinehurst, North Carolina
  115. Rapid City, North Dakota
  116. Cleveland, Ohio
  117. Cleveland, Ohio
  118. Columbus, Ohio
  119. Mayfield Heights, Ohio
  120. Lawton, Oklahoma
  121. Oklahoma City, Oklahoma
  122. Oklahoma City, Oklahoma
  123. Portland, Oregon
  124. Dunmore, Pennsylvania
  125. Hershey, Pennsylvania
  126. Lancaster, Pennsylvania
  127. Philadelphia, Pennsylvania
  128. Philadelphia, Pennsylvania
  129. Philadelphia, Pennsylvania
  130. Philadelphia, Pennsylvania
  131. Pittsburgh, Pennsylvania
  132. Pittsburgh, Pennsylvania
  133. Wyomissing, Pennsylvania
  134. York, Pennsylvania
  135. Providence, Rhode Island
  136. Providence, Rhode Island
  137. Columbia, South Carolina
  138. Aberdeen, South Dakota
  139. Rapid City, South Dakota
  140. Sioux Falls, South Dakota
  141. Nashville, Tennessee
  142. Nashville, Tennessee
  143. Houston, Texas
  144. Houston, Texas
  145. Houston, Texas
  146. Laredo, Texas
  147. Salt Lake City, Utah
  148. Fairfax, Virginia
  149. Richmond, Virginia
  150. Charleston, West Virginia
  151. Appleton, Wisconsin
  152. Green Bay, Wisconsin
  153. La Crosse, Wisconsin
  154. Madison, Wisconsin
  155. Milwaukee, Wisconsin
  156. Milwaukee, Wisconsin
  157. Racine, Wisconsin
  158. Waukesha, Wisconsin
  159. Waukesha, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Breast CancerExemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
NCT00201864
  1. Columbus, Ohio
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
Official Title  ICMJE A STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
Brief Summary A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
Detailed Description To provide access to palbociclib to post-menopausal patients with hormone receptor-positive [HR(+)], HER2-negative [HER2(-)] ABC who are deemed appropriate for letrozole therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Palbociclib
    125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
    Other Name: IBRANCE
  • Drug: Letrozole
    2.5 mg/d tablets orally on a continuous regimen
Study Arms  ICMJE Experimental: Experimental arm
Palbociclib plus Letrozole
Interventions:
  • Drug: Palbociclib
  • Drug: Letrozole
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 14, 2019)		251
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2016)		150
Actual Study Completion Date  ICMJE July 25, 2019
Actual Primary Completion Date July 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate bone marrow, liver, and renal function.

Exclusion Criteria:

  • Prior treatment with any CDK inhibitor .
  • QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
  • High cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
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 Australia,   India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679755
Other Study ID Numbers  ICMJE A5481037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 2019

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