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NotableTrial status: Suspended to RecruitingPrimary completion date: Mar 2021 to Dec 2027 · Study sites: 60 to 52 · Eligibility criteria expanded, about 257 words · 2 morev29Show 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
StoppedTrial status: Recruiting to SuspendedSponsor's reason: suspended temporarily - amending protocolPrimary 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 sitesv27Show 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
MinorRe-verified, no change to tracked fieldsv26
NotablePrimary completion date: Apr 2017 to Apr 2019Study sites: 59 to 60 · Completion date: Jan 2027 to Jan 2029v25Show 2 more changesShow less
Study sites: 59 to 60
Completion date: Jan 2027 to Jan 2029
MinorStudy sites: 58 to 59v24
MinorStudy sites: 56 to 58v23
MinorStudy sites: 55 to 56v22
MinorStudy sites: 54 to 55v21
MinorStudy sites: 53 to 54v20
MinorStudy sites: 52 to 53v19
MinorStudy sites: 51 to 52v18
MinorStudy sites: 50 to 51v17
MinorStudy sites: 49 to 50v16
MinorStudy sites: 48 to 49v15
MinorStudy sites: 46 to 48v14
MinorStudy sites: 42 to 46v13
MinorStudy sites: 39 to 42v12
MinorStudy sites: 38 to 39v11
MinorStudy sites: 34 to 38v10
MinorStudy sites: 31 to 34v9
MinorStudy sites: 30 to 31v8
MinorStudy sites: 2 to 30v7
MinorEnrollment target: 1300 to 1000v6
Minor2 versionsRe-verified since Oct 17, 2014, no change to tracked fieldsv4-v5
MinorStudy sites: 1 to 2v3
NotableTrial status: Not Yet Recruiting to RecruitingSite details revisedv2Show 1 more changeShow less
Site details revised
MinorStudy 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Stopped: an ongoing trial was terminated, suspended or withdrawn.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.