Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

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NCT02142868

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Study Location
CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
Bakersfield, California, 93309, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Breast Cancer (Female)
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 or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)

- ER-positive and/or PR-positive tumor based on local laboratory results

- HER2-negative tumor based on local laboratory results

- Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

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


- Patients who have previously participated in a palbociclib trial or who have received
prior treatment with any CDK inhibitor

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Advanced Breast Cancer (Female)Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
NCT02142868
  1. Bakersfield, California
  2. Washington, District of Columbia
  3. Washington, District of Columbia
  4. Duluth, Georgia
  5. Lawrenceville, Georgia
  6. Chicago, Illinois
  7. Crystal Lake, Illinois
  8. Libertyville, Illinois
  9. Northbrook, Illinois
  10. Peoria, Illinois
  11. Skokie, Illinois
  12. Metairie, Louisiana
  13. Baltimore, Maryland
  14. Lutherville, Maryland
  15. Corinth, Mississippi
  16. Jackson, Mississippi
  17. Jackson, Mississippi
  18. Jackson, Mississippi
  19. Southaven, Mississippi
  20. Lake Success, New York
  21. Portland, Oregon
  22. Portland, Oregon
  23. Beaver, Pennsylvania
  24. Greensburg, Pennsylvania
  25. Greenville, Pennsylvania
  26. Monroeville, Pennsylvania
  27. Pittsburgh, Pennsylvania
  28. Pittsburgh, Pennsylvania
  29. Pittsburgh, Pennsylvania
  30. Pittsburgh, Pennsylvania
  31. Pittsburgh, Pennsylvania
  32. Pittsburgh, Pennsylvania
  33. Seneca, Pennsylvania
  34. State College, Pennsylvania
  35. Germantown, Tennessee
  36. Memphis, Tennessee
  37. Memphis, Tennessee
  38. Dallas, Texas
  39. Houston, Texas
  40. Fairfax, Virginia
  41. Reston, Virginia
  42. Seattle, Washington
  43. Vancouver, Washington
  44. Vancouver, Washington
  45. Calgary, Alberta
  46. Calgary, Alberta
  47. Edmonton, Alberta
  48. Halifax, Nova Scotia
  49. London, Ontario
  50. Ottawa, Ontario
  51. Toronto, Ontario
  52. Toronto, Ontario
  53. Toronto, Ontario
  54. Montreal, Quebec
  55. Quebec,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
Official Title AN EXPANDED ACCESS 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 To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).
Detailed Description This study is currently available in Canada only.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Advanced Breast Cancer (Female)
Intervention
  • Drug: Palbociclib
    Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
    Other Name: Ibrance
  • Drug: Letrozole
    Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
    Other Name: Femara
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
Expanded Access Status No longer available
Eligibility Criteria

Inclusion Criteria:

  • Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
  • ER-positive and/or PR-positive tumor based on local laboratory results
  • HER2-negative tumor based on local laboratory results
  • Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

Exclusion Criteria:

  • Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02142868
Other Study ID Numbers A5481034
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018