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AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.

Study acronym: AURORA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Sponsor changed: Breast International Group to Jules Bordet Institute Collaborators: 2 to 1v31 Show 1 more changeShow less
  2. Minor Site details revised at 6 of 52 sitesv30
  3. Notable Trial status: Suspended to Recruiting Primary completion date: Mar 2021 to Dec 2027 · Study sites: 60 to 52 · Eligibility criteria expanded, about 257 words · 2 morev29 Show 5 more changesShow less
    • Primary completion date: Mar 2021 to Dec 2027
    • Study sites: 60 to 52
    • Eligibility criteria expanded, about 257 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Collaborators revised (2)

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Re-verified, no change to tracked fieldsv28
  5. Stopped Trial status: Recruiting to Suspended Sponsor's reason: suspended temporarily - amending protocol Primary completion date changed from estimate of Apr 2019 to Mar 2021 · Completion date: Jan 2029 to Mar 2031 · Site details revised at 60 of 60 sitesv27 Show 3 more changesShow less
    • Primary completion date changed from estimate of Apr 2019 to Mar 2021
    • Completion date: Jan 2029 to Mar 2031
    • Site details revised at 60 of 60 sites
Show 25 earlier versionsHide 25 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv26
  2. Notable Primary completion date: Apr 2017 to Apr 2019 Study sites: 59 to 60 · Completion date: Jan 2027 to Jan 2029v25 Show 2 more changesShow less
    • Study sites: 59 to 60
    • Completion date: Jan 2027 to Jan 2029
  3. Minor Study sites: 58 to 59v24
  4. Minor Study sites: 56 to 58v23
  5. Minor Study sites: 55 to 56v22
  6. Minor Study sites: 54 to 55v21
  7. Minor Study sites: 53 to 54v20
  8. Minor Study sites: 52 to 53v19
  9. Minor Study sites: 51 to 52v18
  10. Minor Study sites: 50 to 51v17
  11. Minor Study sites: 49 to 50v16
  12. Minor Study sites: 48 to 49v15
  13. Minor Study sites: 46 to 48v14
  14. Minor Study sites: 42 to 46v13
  15. Minor Study sites: 39 to 42v12
  16. Minor Study sites: 38 to 39v11
  17. Minor Study sites: 34 to 38v10
  18. Minor Study sites: 31 to 34v9
  19. Minor Study sites: 30 to 31v8
  20. Minor Study sites: 2 to 30v7
  21. Minor Enrollment target: 1300 to 1000v6
  22. Minor 2 versions Re-verified since Oct 17, 2014, no change to tracked fieldsv4-v5
  23. Minor Study sites: 1 to 2v3
  24. Notable Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer. In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the "right therapy for each individual patient". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.
Trial Details
NCT Number NCT02102165
Lead Sponsor Jules Bordet Institute
Collaborators: Frontier Science & Technology Research Foundation, Inc.
Conditions Metastatic Breast Cancer
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov