Southeast Netherlands Advanced Metastatic Breast Cancer Registry

NCT03577197

Last updated date
Study Location
Multiple hospitals in the Netherlands (see Eligibility)
Maastricht, , , Netherlands
Contact
+31 (0) 43 3877025

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

+31 (0) 43 3877025

By email

Contact

[email protected]

Call Now

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

- Diagnosed with de novo or recurrent advanced breast cancer in 2007-2019

- Diagnosed with or treated for advanced breast cancer in one of the participating hospitals

- Participating hospitals (period of inclusion): Maastricht UMC+ (2007-2019), Zuyderland hospitals Sittard/Heerlen (2007-2019), Amphia Hospital Breda (2007-2019), Catharina Hospital Eindhoven (2007-2019), Elkerliek Hospital Helmond (2007-2019), Maxima Medical Center Veldhoven/Eindhoven (2010-2019), Jeroen Bosch Hospital Den Bosch (2007-2019), Laurentius Hospital Roermond (2007-2019), St. Annaziekenhuis Geldrop (2007-2019), St. Elisabeth Hospital Tilburg (2007-2009), St. Jans Gasthuis Weert (2007-2019), VieCuri Medical Center Venlo/Venray (2007-2014), all in the Netherlands.

- Hospitals (and periods) were eligible for inclusion if (distant) registration from Maastricht UMC+ was possible.

- Other hospitals will be added during the running phase of the study, and possibly the inclusion period may be prolonged after 2020.

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

none

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

Advanced Breast Cancer, Metastatic Breast CancerSoutheast Netherlands Advanced Metastatic Breast Cancer Registry
NCT03577197
  1. Maastricht,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Breast Cancer, Metastatic Breast CancerPalbociclib in Real World Practice
NCT03280303
  1. Allentown, Pennsylvania
  2. Burnaby, British Columbia
  3. Alabaster, Alabama
  4. Bessemer, Alabama
  5. Birmingham, Alabama
  6. Birmingham, Alabama
  7. Birmingham, Alabama
  8. Birmingham, Alabama
  9. Birmingham, Alabama
  10. Birmingham, Alabama
  11. Birmingham, Alabama
  12. Little Rock, Arkansas
  13. Stuttgart, Arkansas
  14. Auburn, California
  15. Bakersfield, California
  16. Beverly Hills, California
  17. Burbank, California
  18. Chico, California
  19. Concord, California
  20. Concord, California
  21. Concord, California
  22. Gilroy, California
  23. Laguna Hills, California
  24. Newport Beach, California
  25. Orange, California
  26. Petaluma, California
  27. Pleasant Hill, California
  28. Pleasant Hill, California
  29. Roseville, California
  30. Sacramento, California
  31. Saint Helena, California
  32. Salinas, California
  33. Salinas, California
  34. San Jose, California
  35. Santa Ana, California
  36. Santa Barbara, California
  37. Santa Barbara, California
  38. Santa Rosa, California
  39. Solvang, California
  40. Stockton, California
  41. Stockton, California
  42. Vacaville, California
  43. Vallejo, California
  44. Walnut Creek, California
  45. Walnut Creek, California
  46. Aurora, Colorado
  47. Boulder, Colorado
  48. Colorado Springs, Colorado
  49. Denver, Colorado
  50. Denver, Colorado
  51. Grand Junction, Colorado
  52. Grand Junction, Colorado
  53. Lakewood, Colorado
  54. Littleton, Colorado
  55. Lone Tree, Colorado
  56. Longmont, Colorado
  57. Parker, Colorado
  58. Pueblo, Colorado
  59. Thornton, Colorado
  60. Danbury, Connecticut
  61. New Milford, Connecticut
  62. Norwalk, Connecticut
  63. Washington, District of Columbia
  64. Boca Raton, Florida
  65. Fleming Island, Florida
  66. Fort Lauderdale, Florida
  67. Jacksonville, Florida
  68. Jacksonville, Florida
  69. Jacksonville, Florida
  70. Jacksonville, Florida
  71. Jacksonville, Florida
  72. Jacksonville, Florida
  73. Lakeland, Florida
  74. Miami, Florida
  75. Miami, Florida
  76. Miami, Florida
  77. Middleburg, Florida
  78. Pembroke, Florida
  79. Plantation, Florida
  80. Saint Augustine, Florida
  81. Sunrise, Florida
  82. Austell, Georgia
  83. Carrollton, Georgia
  84. Cartersville, Georgia
  85. Douglasville, Georgia
  86. Duluth, Georgia
  87. Duluth, Georgia
  88. Lawrenceville, Georgia
  89. Lawrenceville, Georgia
  90. Marietta, Georgia
  91. Roswell, Georgia
  92. Savannah, Georgia
  93. Savannah, Georgia
  94. Savannah, Georgia
  95. Snellville, Georgia
  96. Arlington Heights, Illinois
  97. Bourbonnais, Illinois
  98. Chicago, Illinois
  99. Crystal Lake, Illinois
  100. Crystal Lake, Illinois
  101. Evanston, Illinois
  102. Joliet, Illinois
  103. Libertyville, Illinois
  104. Libertyville, Illinois
  105. Morris, Illinois
  106. New Lenox, Illinois
  107. Normal, Illinois
  108. Quincy, Illinois
  109. Skokie, Illinois
  110. Skokie, Illinois
  111. Newburgh, Indiana
  112. Ames, Iowa
  113. Cedar Rapids, Iowa
  114. Topeka, Kansas
  115. Topeka, Kansas
  116. Westwood, Kansas
  117. Baton Rouge, Louisiana
  118. Baton Rouge, Louisiana
  119. Baton Rouge, Louisiana
  120. Baton Rouge, Louisiana
  121. Covington, Louisiana
  122. Hammond, Louisiana
  123. Marrero, Louisiana
  124. Marrero, Louisiana
  125. Metairie, Louisiana
  126. New Orleans, Louisiana
  127. Baltimore, Maryland
  128. Baltimore, Maryland
  129. Bethesda, Maryland
  130. Chevy Chase, Maryland
  131. Clinton, Maryland
  132. Columbia, Maryland
  133. Frederick, Maryland
  134. Haggerstown, Maryland
  135. Rockville, Maryland
  136. Silver Spring, Maryland
  137. Silver Spring, Maryland
  138. Towson, Maryland
  139. Boston, Massachusetts
  140. Boston, Massachusetts
  141. Newton, Massachusetts
  142. Worcester, Massachusetts
  143. Grosse Pointe Woods, Michigan
  144. Traverse City, Michigan
  145. Warren, Michigan
  146. Burnsville, Minnesota
  147. Coon Rapids, Minnesota
  148. Edina, Minnesota
  149. Edina, Minnesota
  150. Maple Grove, Minnesota
  151. Minneapolis, Minnesota
  152. Saint Louis Park, Minnesota
  153. Saint Louis Park, Minnesota
  154. Saint Louis Park, Minnesota
  155. Saint Paul, Minnesota
  156. Saint Paul, Minnesota
  157. Saint Paul, Minnesota
  158. Stillwater, Minnesota
  159. Willmar, Minnesota
  160. Woodbury, Minnesota
  161. Tupelo, Mississippi
  162. Ballwin, Missouri
  163. Bridgeton, Missouri
  164. Chesterfield, Missouri
  165. Columbia, Missouri
  166. Columbia, Missouri
  167. Kansas City, Missouri
  168. Kansas City, Missouri
  169. Liberty, Missouri
  170. North Kansas City, Missouri
  171. Saint Joseph, Missouri
  172. Saint Louis, Missouri
  173. Saint Louis, Missouri
  174. Saint Louis, Missouri
  175. Lincoln, Nebraska
  176. Portsmouth, New Hampshire
  177. Hackensack, New Jersey
  178. Lakewood, New Jersey
  179. Long Branch, New Jersey
  180. Paramus, New Jersey
  181. Phillipsburg, New Jersey
  182. West Long Branch, New Jersey
  183. Brewster, New York
  184. East Setauket, New York
  185. Mount Kisco, New York
  186. Mount Kisco, New York
  187. Patchogue, New York
  188. Port Jefferson Station, New York
  189. Riverhead, New York
  190. Smithtown, New York
  191. White Plains, New York
  192. Asheville, North Carolina
  193. Clayton, North Carolina
  194. Clyde, North Carolina
  195. Fayetteville, North Carolina
  196. Fayetteville, North Carolina
  197. Greenville, North Carolina
  198. Hendersonville, North Carolina
  199. Henderson, North Carolina
  200. High Point, North Carolina
  201. Kernersville, North Carolina
  202. Laurinburg, North Carolina
  203. Lumberton, North Carolina
  204. Mount Airy, North Carolina
  205. North Wilkesboro, North Carolina
  206. Smithfield, North Carolina
  207. Statesville, North Carolina
  208. Thomasville, North Carolina
  209. Winston-Salem, North Carolina
  210. Canton, Ohio
  211. Canton, Ohio
  212. Columbus, Ohio
  213. Dover, Ohio
  214. Massilon, Ohio
  215. Perrysburg, Ohio
  216. Toledo, Ohio
  217. Toledo, Ohio
  218. Warren, Ohio
  219. Youngstown, Ohio
  220. Eugene, Oregon
  221. Portland, Oregon
  222. Portland, Oregon
  223. Springfield, Oregon
  224. Allentown, Pennsylvania
  225. Bethlehem, Pennsylvania
  226. Bethlehem, Pennsylvania
  227. Bethlehem, Pennsylvania
  228. Easton, Pennsylvania
  229. Harrisburg, Pennsylvania
  230. Harrisburg, Pennsylvania
  231. Mechanicsburg, Pennsylvania
  232. Charleston, South Carolina
  233. Easley, South Carolina
  234. Georgetown, South Carolina
  235. Greenville, South Carolina
  236. Greenville, South Carolina
  237. Greer, South Carolina
  238. Lancaster, South Carolina
  239. Murrells Inlet, South Carolina
  240. Myrtle Beach, South Carolina
  241. Rock Hill, South Carolina
  242. Seneca, South Carolina
  243. Spartanburg, South Carolina
  244. Spartanburg, South Carolina
  245. Sumter, South Carolina
  246. Bristol, Tennessee
  247. Bristol, Tennessee
  248. Chattanooga, Tennessee
  249. Johnson City, Tennessee
  250. Kingsport, Tennessee
  251. Kingsport, Tennessee
  252. Allen, Texas
  253. Dallas, Texas
  254. Denton, Texas
  255. El Paso, Texas
  256. Fort Worth, Texas
  257. Fort Worth, Texas
  258. Fort Worth, Texas
  259. Houston, Texas
  260. Houston, Texas
  261. Lubbock, Texas
  262. McAllen, Texas
  263. McKinney, Texas
  264. Mesquite, Texas
  265. Paris, Texas
  266. Plano, Texas
  267. San Antonio, Texas
  268. San Antonio, Texas
  269. San Antonio, Texas
  270. Tyler, Texas
  271. Arlington, Virginia
  272. Bristol, Virginia
  273. Chesapeake, Virginia
  274. Fairfax, Virginia
  275. Fishersville, Virginia
  276. Gainesville, Virginia
  277. Gloucester, Virginia
  278. Leesburg, Virginia
  279. Mechanicsville, Virginia
  280. Mechanicsville, Virginia
  281. Midlothian, Virginia
  282. Midlothian, Virginia
  283. Midlothian, Virginia
  284. Nassawadox, Virginia
  285. Newport News, Virginia
  286. Norton, Virginia
  287. Richmond, Virginia
  288. Richmond, Virginia
  289. Suffolk, Virginia
  290. Virginia Beach, Virginia
  291. Williamsburg, Virginia
  292. Seattle, Washington
  293. Vancouver, Washington
  294. Bridgeport, West Virginia
  295. Huntington, West Virginia
  296. Huntington, West Virginia
  297. Morgantown, West Virginia
  298. Parkersburg, West Virginia
  299. Mississauga, Ontario
  300. Toronto, Ontario
  301. Chicoutimi, Quebec
  302. San Juan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Southeast Netherlands Advanced Metastatic Breast Cancer Registry
Official Title Southeast Netherlands Advanced Breast Cancer Registry
Brief Summary The Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry is a real life multi-center study. The registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 14 hospitals in the Netherlands. Data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks.
Detailed Description This SONABRE registry is an ongoing observational cohort study aiming at the inclusion of all patients aged ?18 years and diagnosed with advanced breast cancer in 2007-2019 in 14 hospitals in the Southeast of the Netherlands. Patients with de novo or recurrent advanced breast cancer were identified from the hospital-based management information systems. Specially trained registration clerks retrospectively collected data from the medical files of the patients based on extensive medical chart review. Information was collected about patient and tumour characteristics, type of treatment (surgery, radiotherapy and systemic treatment, both neo-adjuvant, adjuvant and palliative), palliative treatment changes due to adverse events, hospitalization, comorbidities and outcomes (progression and death). The SONABRE Registry has already been effectively used to perform real-life studies on safety and (cost-)effectiveness of various systemic treatments used in patients diagnosed with advanced breast cancer.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All consecutive patient diagnosed with advanced breast cancer between 2007-2019 in 14 hospitals in the Netherlands. No patients are being excluded. Also patients with no systemic / active antitumor therapy for advanced breast cancer will be included. The SONABRE Registry includes 14 hospitals: 1 academic, 7 teaching and 6 general hospitals. The Netherlands counts 114 hospitals, including 8 academic, 25 teaching, 58 general and 23 categorical hospitals.
Condition
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 2, 2018)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed with de novo or recurrent advanced breast cancer in 2007-2019
  • Diagnosed with or treated for advanced breast cancer in one of the participating hospitals
  • Participating hospitals (period of inclusion): Maastricht UMC+ (2007-2019), Zuyderland hospitals Sittard/Heerlen (2007-2019), Amphia Hospital Breda (2007-2019), Catharina Hospital Eindhoven (2007-2019), Elkerliek Hospital Helmond (2007-2019), Maxima Medical Center Veldhoven/Eindhoven (2010-2019), Jeroen Bosch Hospital Den Bosch (2007-2019), Laurentius Hospital Roermond (2007-2019), St. Annaziekenhuis Geldrop (2007-2019), St. Elisabeth Hospital Tilburg (2007-2009), St. Jans Gasthuis Weert (2007-2019), VieCuri Medical Center Venlo/Venray (2007-2014), all in the Netherlands.
  • Hospitals (and periods) were eligible for inclusion if (distant) registration from Maastricht UMC+ was possible.
  • Other hospitals will be added during the running phase of the study, and possibly the inclusion period may be prolonged after 2020.

Exclusion Criteria: none

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Vivianne CG Tjan-Heijnen, MD, PhD+31 (0) 43 3877025[email protected]
Contact: Sandra ME Geurts, PhD+31 (0) 43 3875217[email protected]
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03577197
Other Study ID Numbers MUMC-MO-2015-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party V.C.G. Tjan-Heijnen, Academisch Ziekenhuis Maastricht
Study Sponsor Academisch Ziekenhuis Maastricht
Collaborators
  • Novartis
  • Pfizer
  • Roche Pharma AG
Investigators Not Provided
PRS Account Academisch Ziekenhuis Maastricht
Verification Date November 2019