A Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

NCT02040857

Last updated date
Study Location
University of California, San Francisco
San Francisco, California, 94115, United States
Contact
1-800-718-1021

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
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

- Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.

- Men and both pre- and postmenopausal women are eligible.

- Prior Treatment:

- Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.

- Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.

- If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.

- Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.

- ECOG performance status 0-1

- Age ≥18 years.

- Normal organ and marrow function

- Baseline QTc ≤ 480 ms

- The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception

- Ability to understand and the willingness to sign a written informed consent document

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


- Concurrent therapy with other investigational agents.


- Prior therapy with any CDK4/6 inhibitor.


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to palbociclib.


- Participants receiving any medications or substances that are strong inhibitors or
inducers of CYP3A isoenzymes are ineligible.


- Current use of drugs that are known to prolong the QT interval


- Subjects with organ allograft requiring immunosuppression.


- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.


- Pregnant women are excluded from this study. Breastfeeding should be discontinued
prior to entry onto the study.


- Individuals with a history of a different malignancy are ineligible except for the
following circumstances. Individuals with a history of other malignancies are eligible
if they have been disease-free for at least 5 years and are deemed by the investigator
to be at low risk for recurrence of that malignancy. Individuals with the following
cancers are eligible if diagnosed and treated within the past 5 years: ductal
carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous
cell carcinoma of the skin.


- No ongoing combination antiretroviral therapy

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]

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.

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 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
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
Official Title  ICMJE A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Carcinoma
Brief Summary

This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer.

  • Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to regulate cell growth. Laboratory testing has suggested palbociclib may stop the growth of hormone receptor positive breast cancer.
  • Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation. During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor. It is standard of care for premenopausal women to take tamoxifen and for postmenopausal women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone receptor positive breast cancer.
Detailed Description

After the screening procedures confirms that the participant is able to participate in the study. The participant will be given a dosing diary for each treatment cycle. Each treatment cycle lasts 28 days, during which time the participant will take Palbociclib once a day on days 1-21 of each 28 day cycle and the aromatase inhibitor that the participant is already taking once a day every day. The diary will also include special instructions for taking the study drug(s).

All participants participating in the research study will receive the same dose of Palbociclib.

While participating in the research study the participant will have the following tests and procedures:

  • Clinical Exams: The participant will have a physical exam on the first day of the month for first three months of therapy. After that, the participant will have a physical exam every other month until the end of the first year of therapy. After the first year, the participant will have a physical exam every 3 months during the second year of therapy. During the physical exam, the participant will be asked questions about their general health, questions about any problems that they may be experiencing, and any medications they are taking.
  • Blood tests: The participant will have blood drawn on the first and fifteenth days of the first three months of therapy. After that, the participant will have blood drawn every month for the remainder of the first year of treatment and the every other month until the end of therapy. These tests will be used to determine if the participant is having any side effects related to the study drug.
  • Electrocardiograms (EKG): The participant will have an EKG performed on the first day of the first three months of therapy. After that, the participant will have an EKG every other month until the end of the first year of therapy. After the first year of therapy, the participant will have an EKG every 3 months during the second year of therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Palbociclib
    CDK 4/6 inhibitor
    Other Names:
    • PD 0332991-0054
    • PD-0332991
    • PD-332991
    • PF-00080665-73
  • Drug: Endocrine Therapy
    Endocrine Therapy
    Other Names:
    • Femara
    • Letrozole
    • Anastrozole
    • Arimidex
    • Exemestane
    • Aromasin
    • Tamoxifen
    • Nolvadex
Study Arms  ICMJE Experimental: Palbociclib, Aromatase Inhibitor
  • Palbociclib 125 mg PO qd 21 days on, 7 days off
  • Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
Interventions:
  • Drug: Palbociclib
  • Drug: Endocrine Therapy
Publications * Mayer EL, DeMichele A, Rugo HS, Miller K, Waks AG, Come SE, Mulvey T, Jeselsohn R, Overmoyer B, Guo H, Barry WT, Huang Bartlett C, Koehler M, Winer EP, Burstein HJ. A phase II feasibility study of palbociclib in combination with adjuvant endocrine therapy for hormone receptor-positive invasive breast carcinoma. Ann Oncol. 2019 Sep 1;30(9):1514-1520. doi: 10.1093/annonc/mdz198.

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2015)
160
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2014)
120
Estimated Study Completion Date  ICMJE May 2020
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.
  • Men and both pre- and postmenopausal women are eligible.
  • Prior Treatment:

    • Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.
    • Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.
    • If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.
  • Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.
  • ECOG performance status 0-1
  • Age ?18 years.
  • Normal organ and marrow function
  • Baseline QTc ? 480 ms
  • The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Concurrent therapy with other investigational agents.
  • Prior therapy with any CDK4/6 inhibitor.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.
  • Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.
  • Current use of drugs that are known to prolong the QT interval
  • Subjects with organ allograft requiring immunosuppression.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study. Breastfeeding should be discontinued prior to entry onto the study.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • No ongoing combination antiretroviral therapy
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02040857
Other Study ID Numbers  ICMJE 13-559
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erica Mayer, MD, MPH, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Erica Mayer, MD, MPHDana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date November 2019

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