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

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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

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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. Jacksonville, Florida
  2. Alabaster, Alabama
  3. Bessemer, Alabama
  4. Birmingham, Alabama
  5. Birmingham, Alabama
  6. Birmingham, Alabama
  7. Birmingham, Alabama
  8. Birmingham, Alabama
  9. Birmingham, Alabama
  10. Birmingham, Alabama
  11. Little Rock, Arkansas
  12. Stuttgart, Arkansas
  13. Auburn, California
  14. Bakersfield, California
  15. Beverly Hills, California
  16. Burbank, California
  17. Chico, California
  18. Concord, California
  19. Concord, California
  20. Concord, California
  21. Gilroy, California
  22. Laguna Hills, California
  23. Newport Beach, California
  24. Orange, California
  25. Petaluma, California
  26. Pleasant Hill, California
  27. Pleasant Hill, California
  28. Roseville, California
  29. Sacramento, California
  30. Saint Helena, California
  31. Salinas, California
  32. Salinas, California
  33. San Jose, California
  34. Santa Ana, California
  35. Santa Barbara, California
  36. Santa Barbara, California
  37. Santa Rosa, California
  38. Solvang, California
  39. Stockton, California
  40. Stockton, California
  41. Vacaville, California
  42. Vallejo, California
  43. Walnut Creek, California
  44. Walnut Creek, California
  45. Aurora, Colorado
  46. Boulder, Colorado
  47. Colorado Springs, Colorado
  48. Denver, Colorado
  49. Denver, Colorado
  50. Grand Junction, Colorado
  51. Grand Junction, Colorado
  52. Lakewood, Colorado
  53. Littleton, Colorado
  54. Lone Tree, Colorado
  55. Longmont, Colorado
  56. Parker, Colorado
  57. Pueblo, Colorado
  58. Thornton, Colorado
  59. Danbury, Connecticut
  60. New Milford, Connecticut
  61. Norwalk, Connecticut
  62. Washington, District of Columbia
  63. Boca Raton, Florida
  64. Fleming Island, Florida
  65. Fort Lauderdale, Florida
  66. Jacksonville, Florida
  67. Jacksonville, Florida
  68. Jacksonville, Florida
  69. Jacksonville, Florida
  70. Jacksonville, Florida
  71. Jacksonville, Florida
  72. Lakeland, Florida
  73. Miami, Florida
  74. Miami, Florida
  75. Miami, Florida
  76. Middleburg, Florida
  77. Pembroke, Florida
  78. Plantation, Florida
  79. Saint Augustine, Florida
  80. Sunrise, Florida
  81. Austell, Georgia
  82. Carrollton, Georgia
  83. Cartersville, Georgia
  84. Douglasville, Georgia
  85. Duluth, Georgia
  86. Duluth, Georgia
  87. Lawrenceville, Georgia
  88. Lawrenceville, Georgia
  89. Marietta, Georgia
  90. Roswell, Georgia
  91. Savannah, Georgia
  92. Savannah, Georgia
  93. Savannah, Georgia
  94. Snellville, Georgia
  95. Arlington Heights, Illinois
  96. Bourbonnais, Illinois
  97. Chicago, Illinois
  98. Crystal Lake, Illinois
  99. Crystal Lake, Illinois
  100. Evanston, Illinois
  101. Joliet, Illinois
  102. Libertyville, Illinois
  103. Libertyville, Illinois
  104. Morris, Illinois
  105. New Lenox, Illinois
  106. Normal, Illinois
  107. Quincy, Illinois
  108. Skokie, Illinois
  109. Skokie, Illinois
  110. Newburgh, Indiana
  111. Ames, Iowa
  112. Cedar Rapids, Iowa
  113. Topeka, Kansas
  114. Topeka, Kansas
  115. Westwood, Kansas
  116. Baton Rouge, Louisiana
  117. Baton Rouge, Louisiana
  118. Baton Rouge, Louisiana
  119. Baton Rouge, Louisiana
  120. Covington, Louisiana
  121. Hammond, Louisiana
  122. Marrero, Louisiana
  123. Marrero, Louisiana
  124. Metairie, Louisiana
  125. New Orleans, Louisiana
  126. Baltimore, Maryland
  127. Baltimore, Maryland
  128. Bethesda, Maryland
  129. Chevy Chase, Maryland
  130. Clinton, Maryland
  131. Columbia, Maryland
  132. Frederick, Maryland
  133. Haggerstown, Maryland
  134. Rockville, Maryland
  135. Silver Spring, Maryland
  136. Silver Spring, Maryland
  137. Towson, Maryland
  138. Boston, Massachusetts
  139. Newton, Massachusetts
  140. Worcester, Massachusetts
  141. Grosse Pointe Woods, Michigan
  142. Traverse City, Michigan
  143. Warren, Michigan
  144. Burnsville, Minnesota
  145. Coon Rapids, Minnesota
  146. Edina, Minnesota
  147. Edina, Minnesota
  148. Maple Grove, Minnesota
  149. Minneapolis, Minnesota
  150. Saint Louis Park, Minnesota
  151. Saint Louis Park, Minnesota
  152. Saint Louis Park, Minnesota
  153. Saint Paul, Minnesota
  154. Saint Paul, Minnesota
  155. Saint Paul, Minnesota
  156. Stillwater, Minnesota
  157. Willmar, Minnesota
  158. Woodbury, Minnesota
  159. Tupelo, Mississippi
  160. Ballwin, Missouri
  161. Bridgeton, Missouri
  162. Chesterfield, Missouri
  163. Columbia, Missouri
  164. Columbia, Missouri
  165. Kansas City, Missouri
  166. Kansas City, Missouri
  167. Liberty, Missouri
  168. North Kansas City, Missouri
  169. Saint Joseph, Missouri
  170. Saint Louis, Missouri
  171. Saint Louis, Missouri
  172. Saint Louis, Missouri
  173. Lincoln, Nebraska
  174. Portsmouth, New Hampshire
  175. Hackensack, New Jersey
  176. Paramus, New Jersey
  177. Phillipsburg, New Jersey
  178. Brewster, New York
  179. East Setauket, New York
  180. Mount Kisco, New York
  181. Mount Kisco, New York
  182. Patchogue, New York
  183. Port Jefferson Station, New York
  184. Riverhead, New York
  185. Smithtown, New York
  186. White Plains, New York
  187. Asheville, North Carolina
  188. Clayton, North Carolina
  189. Clyde, North Carolina
  190. Fayetteville, North Carolina
  191. Fayetteville, North Carolina
  192. Greenville, North Carolina
  193. Hendersonville, North Carolina
  194. Henderson, North Carolina
  195. High Point, North Carolina
  196. Kernersville, North Carolina
  197. Laurinburg, North Carolina
  198. Lumberton, North Carolina
  199. Mount Airy, North Carolina
  200. North Wilkesboro, North Carolina
  201. Smithfield, North Carolina
  202. Statesville, North Carolina
  203. Thomasville, North Carolina
  204. Winston-Salem, North Carolina
  205. Canton, Ohio
  206. Canton, Ohio
  207. Columbus, Ohio
  208. Dover, Ohio
  209. Massilon, Ohio
  210. Perrysburg, Ohio
  211. Toledo, Ohio
  212. Toledo, Ohio
  213. Warren, Ohio
  214. Youngstown, Ohio
  215. Eugene, Oregon
  216. Portland, Oregon
  217. Portland, Oregon
  218. Springfield, Oregon
  219. Allentown, Pennsylvania
  220. Allentown, Pennsylvania
  221. Bethlehem, Pennsylvania
  222. Bethlehem, Pennsylvania
  223. Bethlehem, Pennsylvania
  224. Easton, Pennsylvania
  225. Harrisburg, Pennsylvania
  226. Harrisburg, Pennsylvania
  227. Mechanicsburg, Pennsylvania
  228. Charleston, South Carolina
  229. Easley, South Carolina
  230. Georgetown, South Carolina
  231. Greenville, South Carolina
  232. Greenville, South Carolina
  233. Greer, South Carolina
  234. Lancaster, South Carolina
  235. Murrells Inlet, South Carolina
  236. Myrtle Beach, South Carolina
  237. Rock Hill, South Carolina
  238. Seneca, South Carolina
  239. Spartanburg, South Carolina
  240. Spartanburg, South Carolina
  241. Sumter, South Carolina
  242. Bristol, Tennessee
  243. Bristol, Tennessee
  244. Chattanooga, Tennessee
  245. Johnson City, Tennessee
  246. Kingsport, Tennessee
  247. Kingsport, Tennessee
  248. Allen, Texas
  249. Dallas, Texas
  250. Denton, Texas
  251. El Paso, Texas
  252. Fort Worth, Texas
  253. Fort Worth, Texas
  254. Fort Worth, Texas
  255. Houston, Texas
  256. Houston, Texas
  257. Lubbock, Texas
  258. McAllen, Texas
  259. McKinney, Texas
  260. Mesquite, Texas
  261. Paris, Texas
  262. Plano, Texas
  263. San Antonio, Texas
  264. San Antonio, Texas
  265. San Antonio, Texas
  266. Tyler, Texas
  267. Arlington, Virginia
  268. Bristol, Virginia
  269. Chesapeake, Virginia
  270. Fairfax, Virginia
  271. Fishersville, Virginia
  272. Gainesville, Virginia
  273. Gloucester, Virginia
  274. Leesburg, Virginia
  275. Mechanicsville, Virginia
  276. Mechanicsville, Virginia
  277. Midlothian, Virginia
  278. Midlothian, Virginia
  279. Midlothian, Virginia
  280. Nassawadox, Virginia
  281. Newport News, Virginia
  282. Norton, Virginia
  283. Richmond, Virginia
  284. Richmond, Virginia
  285. Suffolk, Virginia
  286. Virginia Beach, Virginia
  287. Williamsburg, Virginia
  288. Seattle, Washington
  289. Vancouver, Washington
  290. Bridgeport, West Virginia
  291. Huntington, West Virginia
  292. Huntington, West Virginia
  293. Morgantown, West Virginia
  294. Parkersburg, West Virginia
  295. Burnaby, British Columbia
  296. Mississauga, Ontario
  297. Toronto, Ontario
  298. Chicoutimi, Quebec
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