A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Back to Search
Print
Bookmark Trial

NCT02297438

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, 233004, China
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 Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy

- Confirmed diagnosis of ER positive breast cancer

- No prior systemic anti-cancer therapy for advanced ER+ disease

- Postmenopausal women

- Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease

- Eastern Cooperative Oncology Group [ECOG] 0-1

- Adequate organ and marrow function

- Patient must agree to provide tumor tissue

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


- Confirmed diagnosis of HER2 positive disease


- Patients with advanced, symptomatic, visceral spread that are at risk of life
threatening complication in the short term


- Known uncontrolled or symptomatic CNS metastases


- Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie,
anastrozole or letrozole) with disease recurrence while on or within 12 months of
completing treatment


- Prior treatment with any CDK 4/6 inhibitor

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 NeoplasmsPD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer
NCT01723774
  1. Birmingham, Alabama
  2. Scottsdale, Arizona
  3. Rochester, Minnesota
  4. Saint Louis, Missouri
Female
18 Years+
years
MULTIPLE SITES
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
  6. Plantation, Florida
  7. Lexington, Kentucky
  8. Lexington, Kentucky
  9. Lexington, Kentucky
  10. Boston, Massachusetts
  11. Boston, Massachusetts
  12. Boston, Massachusetts
  13. Boston, Massachusetts
  14. Boston, Massachusetts
  15. Boston, Massachusetts
  16. Minneapolis, Minnesota
  17. Minneapolis, Minnesota
  18. Minneapolis, Minnesota
  19. Burlington, North Carolina
  20. Durham, North Carolina
  21. Durham, North Carolina
  22. Durham, North Carolina
  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Dallas, Texas
  26. Houston, Texas
  27. Houston, Texas
  28. Burlington, Vermont
  29. Burlington, Vermont
  30. Burlington, Vermont
  31. Burlington, Vermont
  32. Burlington, Vermont
  33. Burlington, Vermont
  34. La Plata, Buenos Aires
  35. La Plata, Buenos Aires
  36. La Plata, Buenos Aires
  37. La Plata, Buenos Aires
  38. Rosario, Santa Fe
  39. Rosario, Santa Fe
  40. Rosario, Santa Fe
  41. Rosario, Santa Fé
  42. Cordoba,
  43. Leuven,
  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
  51. Porto Alegre, RS
  52. Sao Paulo, SP
  53. Porto Alegre,
  54. Rio De Janeiro,
  55. Edmonton, Alberta
  56. Montreal, Quebec
  57. Milano,
  58. Napoli,
  59. Padova,
  60. Amsterdam,
  61. Malmo,
  62. London,
  63. London,
Female
18 Years+
years
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
  54. Aurora, Colorado
  55. Boulder, Colorado
  56. Colorado Springs, Colorado
  57. Colorado Springs, Colorado
  58. Denver, Colorado
  59. Denver, Colorado
  60. Lakewood, Colorado
  61. Littleton, Colorado
  62. Lone Tree, Colorado
  63. Longmont, Colorado
  64. Parker, Colorado
  65. Thornton, Colorado
  66. Norwalk, Connecticut
  67. Boca Raton, Florida
  68. Coral Springs, Florida
  69. Davie, Florida
  70. Hollywood, Florida
  71. Inverness, Florida
  72. Lakeland, Florida
  73. Melbourne, Florida
  74. Miami, Florida
  75. Miami, Florida
  76. Miami, Florida
  77. Orlando, Florida
  78. Pembroke Pines, Florida
  79. Tampa, Florida
  80. Winter Park, Florida
  81. Atlanta, Georgia
  82. Atlanta, Georgia
  83. Columbus, Georgia
  84. Columbus, Georgia
  85. Decatur, Georgia
  86. Macon, Georgia
  87. Marietta, Georgia
  88. Chicago, Illinois
  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
  121. Burlington, Massachusetts
  122. Peabody, Massachusetts
  123. Coon Rapids, Minnesota
  124. Robbinsdale, Minnesota
  125. Ocean Springs, Mississippi
  126. Pascagoula, Mississippi
  127. Columbia, Missouri
  128. Kansas City, Missouri
  129. Kansas City, Missouri
  130. Kansas City, Missouri
  131. Lee's Summit, Missouri
  132. Fremont, Nebraska
  133. Grand Island, Nebraska
  134. Lincoln, Nebraska
  135. Lincoln, Nebraska
  136. Lincoln, Nebraska
  137. Lincoln, Nebraska
  138. Henderson, Nevada
  139. Henderson, Nevada
  140. Las Vegas, Nevada
  141. Las Vegas, Nevada
  142. Las Vegas, Nevada
  143. Las Vegas, Nevada
  144. Las Vegas, Nevada
  145. Las Vegas, Nevada
  146. Albuquerque, New Mexico
  147. Albuquerque, New Mexico
  148. Buffalo, New York
  149. Corning, New York
  150. Jamaica, New York
  151. Mineola, New York
  152. Cary, North Carolina
  153. Clinton, North Carolina
  154. Durham, North Carolina
  155. Goldsboro, North Carolina
  156. Hickory, North Carolina
  157. Kenansville, North Carolina
  158. Kinston, North Carolina
  159. Lenoir, North Carolina
  160. Pollocksville, North Carolina
  161. Raleight, North Carolina
  162. Raliegh, North Carolina
  163. Richlands, North Carolina
  164. Washington, North Carolina
  165. Wilson, North Carolina
  166. Winston-Salem, North Carolina
  167. Canton, Ohio
  168. Dover, Ohio
  169. Eugene, Oregon
  170. Portland, Oregon
  171. Portland, Oregon
  172. Portland, Oregon
  173. Portland, Oregon
  174. Springfield, Oregon
  175. Tualatin, Oregon
  176. Allentown, Pennsylvania
  177. Bethlehem, Pennsylvania
  178. Ephrata, Pennsylvania
  179. Hershey, Pennsylvania
  180. Kingston, Pennsylvania
  181. Pittsburgh, Pennsylvania
  182. Pittsburgh, Pennsylvania
  183. Sayre, Pennsylvania
  184. Charleston, South Carolina
  185. Easley, South Carolina
  186. Greenville, South Carolina
  187. Greenville, South Carolina
  188. Seneca, South Carolina
  189. Spartanburg, South Carolina
  190. Bristol, Tennessee
  191. Kingsport, Tennessee
  192. Amarillo, Texas
  193. Antonio, Texas
  194. Austin, Texas
  195. Austin, Texas
  196. Austin, Texas
  197. Austin, Texas
  198. Bedford, Texas
  199. Corpus Christi, Texas
  200. Dallas, Texas
  201. Dallas, Texas
  202. Fort Worth, Texas
  203. Fort Worth, Texas
  204. Fort Worth, Texas
  205. Forth Worth, Texas
  206. Houston, Texas
  207. Houston, Texas
  208. Houston, Texas
  209. Kerrville, Texas
  210. Longview, Texas
  211. Midland, Texas
  212. Round Rock, Texas
  213. Round Rock, Texas
  214. Round Rock, Texas
  215. San Antonio, Texas
  216. San Antonio, Texas
  217. San Marcos, Texas
  218. Shenandoah, Texas
  219. Tyler, Texas
  220. Waco, Texas
  221. Ogden, Utah
  222. Arlington, Virginia
  223. Christiansburg, Virginia
  224. Fairfax, Virginia
  225. Leesburg, Virginia
  226. Norton, Virginia
  227. Roanoke, Virginia
  228. Salem, Virginia
  229. Woodbridge, Virginia
  230. Wytheville, Virginia
  231. Federal Way, Washington
  232. Kennewick, Washington
  233. Lakewood, Washington
  234. Moses Lake, Washington
  235. Puyallup, Washington
  236. Tacoma, Washington
  237. Vancouver, Washington
  238. Vancouver, Washington
  239. Wenatchee, Washington
  240. Huntington, West Virginia
  241. Morgantown, West Virginia
  242. Berlin,
  243. Hamburg,
  244. Trier,
  245. Cremona,
  246. Grosseto,
  247. Olbia,
  248. Cabueñes, Gijon
  249. Guadalajara,
  250. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Breast NeoplasmsA Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
NCT00435409
  1. Downey, California
  2. Fresno, California
  3. Montebello, California
  4. Whittier, California
  5. Boca Raton, Florida
  6. Boynton Beach, Florida
  7. Coral Springs, Florida
  8. Hollywood, Florida
  9. Lake Worth, Florida
  10. Lakeland, Florida
  11. Miami, Florida
  12. Miami, Florida
  13. Miami, Florida
  14. Pembroke Pines, Florida
  15. Duluth, Georgia
  16. Lawrenceville, Georgia
  17. Snellville, Georgia
  18. Avon, Indiana
  19. Indianapolis, Indiana
  20. Mooresville, Indiana
  21. Covington, Louisiana
  22. Gretna, Louisiana
  23. Marrero, Louisiana
  24. Metairie, Louisiana
  25. Metairie, Louisiana
  26. New Orleans, Louisiana
  27. Shreveport, Louisiana
  28. Kensington, Maryland
  29. Rockville, Maryland
  30. Corinth, Mississippi
  31. Columbia, Missouri
  32. Billings, Montana
  33. Albuquerque, New Mexico
  34. Albuquerque, New Mexico
  35. Charlotte, North Carolina
  36. Charlotte, North Carolina
  37. Charlotte, North Carolina
  38. Charlotte, North Carolina
  39. Charlotte, North Carolina
  40. Norman, Oklahoma
  41. Oklahoma City, Oklahoma
  42. Tulsa, Oklahoma
  43. Tulsa, Oklahoma
  44. Tulsa, Oklahoma
  45. Clairton, Pennsylvania
  46. Greensburg, Pennsylvania
  47. Pittsburgh, Pennsylvania
  48. Pittsburgh, Pennsylvania
  49. Pottstown, Pennsylvania
  50. Wexford, Pennsylvania
  51. Franklin, Tennessee
  52. Gallatin, Tennessee
  53. Hermitage, Tennessee
  54. Lebanon, Tennessee
  55. Memphis, Tennessee
  56. Murfreesboro, Tennessee
  57. Nashville, Tennessee
  58. Nashville, Tennessee
  59. Nashville, Tennessee
  60. Nashville, Tennessee
  61. Smyrna, Tennessee
  62. Austin, Texas
  63. Austin, Texas
  64. Austin, Texas
  65. Austin, Texas
  66. Beaumont, Texas
  67. Corpus Christi, Texas
  68. Corpus Christi, Texas
  69. Georgetown, Texas
  70. Bountiful, Utah
  71. Layton, Utah
  72. Murray, Utah
  73. Salt Lake City, Utah
  74. Salt Lake City, Utah
  75. West Provo, Utah
  76. West Valley City, Utah
  77. Richmond, Virginia
  78. Richmond, Virginia
  79. Kennewick, Washington
  80. Linz,
  81. Salzburg,
  82. Wels,
  83. Leuven,
  84. Liege,
  85. Namur,
  86. Turnhout,
  87. Yvoir,
  88. Calgary, Alberta
  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,
  100. Koebenhavn OE,
  101. Odense,
  102. Montpellier, Cedex 05
  103. Angers cedex 01,
  104. BORDEAUX Cedex,
  105. CAEN Cedex 5,
  106. Lyon,
  107. Nancy,
  108. Paris,
  109. Erlangen,
  110. Frankenthal,
  111. Frankfurt am Main,
  112. Fuerstenwalde,
  113. Goettingen,
  114. Muenster,
  115. Nuernberg,
  116. Stendal,
  117. Ulm,
  118. Voelklingen,
  119. Heraklion, Crete
  120. Athens,
  121. Ioannina,
  122. Patras,
  123. Thessaloniki,
  124. Dublin,
  125. Dublin,
  126. Dublin,
  127. Bologna,
  128. Brescia,
  129. Messina,
  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,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
Official Title  ICMJE A MULTICENTER, RANDOMIZED, DOUBLE-BLIND PHASE 3 STUDY OF PALBOCICLIB (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF PREVIOUSLY UNTREATED ASIAN POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) ADVANCED BREAST CANCER
Brief Summary The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Palbociclib
    Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
    Other Name: PD-0332991
  • Drug: Letrozole
    Letrozole, 2.5mg, orally once daily (continuously)
  • Drug: Placebo
    Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Study Arms  ICMJE
  • Experimental: Palbociclib + Letrozole
    Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously)
    Interventions:
    • Drug: Palbociclib
    • Drug: Letrozole
  • Active Comparator: Placebo + Letrozole
    Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
    Interventions:
    • Drug: Placebo
    • 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 8, 2018)		339
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2014)		330
Estimated Study Completion Date  ICMJE December 2, 2022
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult Asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy
  • Confirmed diagnosis of ER positive breast cancer
  • No prior systemic anti-cancer therapy for advanced ER+ disease
  • Postmenopausal women
  • Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease
  • Eastern Cooperative Oncology Group [ECOG] 0-1
  • Adequate organ and marrow function
  • Patient must agree to provide tumor tissue

Exclusion Criteria:

  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
  • Prior treatment with any CDK 4/6 inhibitor
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 70 Years   (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 China,   Hong Kong,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02297438
Other Study ID Numbers  ICMJE A5481027
Has Data Monitoring Committee Yes
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 August 2019

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