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

Primary Purpose

Metastatic Breast Cancer

Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
metastatic lesion biopsy
Sponsored by
Breast International Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Metastatic Breast Cancer focused on measuring Aurora, breast cancer, metastatic, molecular screening, targeted gene sequencing, molecular aberrations, exploratory, biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women or men with metastatic or locally relapsed breast cancer manageable with systemic therapy
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  3. Written informed consent prior to enrollment into the program.
  4. Patient aged ≥ 18 years
  5. Patient agrees to provide archived primary tumor tissue
  6. Patient agrees to provide newly collected metastatic lesions tissue samples (archived material up to 6 months is allowed provided both Formalin Fixed Paraffin Embedded (FFPE) block and Frozen Tissue are available and were collected from the same lesion at the same time)
  7. Patient agrees to provide blood samples

Exclusion Criteria:

  1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting
  2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy
  3. Patients with bone-only metastatic disease
  4. Patients with brain-only metastatic disease, unless surgical excision is planned (in which case tissue will be collected for AURORA purpose)
  5. Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI)
  6. Platelet count<100 000/mm3, INR>1.5 (international normalized ratio; blood clotting time) , Albumin<30
  7. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin
  8. Any anti-VEGF (vascular endothelial growth factor) or anti-VEGFR (vascular endothelial growth factor receptor) treatment administered less than 4 weeks before new biopsy procedure or no appropriate wash-out period for patients on anticoagulation therapy

Sites / Locations

  • Institut Jules Bordet
  • Cliniques Universitaires St-Luc
  • Grand Hopital Charleroi
  • UZA, Antwerp University Hospital
  • UZ Leuven
  • CHU de Liège
  • Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)
  • Sint-Augustinus
  • Luisenkrankenhaus
  • Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum
  • University Medical Center Freiburg
  • University of Schleswig-Holstein / Campus Luebeck
  • Sana Klinikum Offenbach
  • Klinikum Oldenburg gGmbH
  • Landspitali
  • Ospedale degli Infermi - S.O.C.Oncologia
  • Ospedale di Bolzano - Oncologia Medica
  • Ospedale Ramazzini di Carpi
  • Az. Istituti Ospitalieri di Cremona
  • IRCCS AOU San Martino-IST
  • ULSS 21 Legnago
  • Istituto Europeo di Oncologia
  • UOC Oncologia Medica - AOU Parma
  • Fondazione Salvatore Maugeri
  • IRCCS Az Ospedaliera S.Maria Nuova
  • Centre Hospitalier
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • Champalimaud Foundation
  • Complexo Hospitalario Universitario A Coruña
  • Hospital del Mar
  • Dr Rosell Oncology Institute, Quirón Dexeus University Hospital
  • Hospital Vall d'Hebron
  • Consorcio Hospitalario Provincial de Castellón
  • Hospital San Pedro de Alcantara
  • Hospital Universitari Arnau de Vilanova
  • MD Anderson Cancer Center
  • Hospital Clínico San Carlos
  • Hospital Universitario 12 de Octubre
  • Centro Integral Oncológico Clara Campa
  • Hospital Universitario Virgen del Rocio
  • Instituto Valenciano de Oncología
  • Hospital Clinico Universitario de Valencia
  • Hospital General Universitario de Valencia
  • Sahlgrenska University Hospital
  • Ryhov County Hospital
  • Kantonsspital Baden
  • Inselspital Bern
  • Kantonsspital Graubuenden
  • Luzerner Kantonsspital, Division of Medical Oncology
  • Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation Trust
  • Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
  • NHS Tayside, Ninewells Hospital
  • Edinburgh Cancer Centre - Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • Christie NHS Foundation Trust
  • Nottingham University Hospital NHS Trust
  • Velindre NHS Trust
  • Singleton Hospital - ABM University Health Board
  • Yeovil District Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metastatic lesion biopsy

Arm Description

biopsy of metastatic lesion will be performed at program inclusion or maximum 6 months prior to inclusion. Sample of primary tumor must be available at inclusion.

Outcomes

Primary Outcome Measures

Metastatic Breast Cancer (MBC) understanding
To improve the understanding of MBC by performing high coverage Targeted Gene Sequencing (TGS) and RNA sequencing on matched primary and metastatic samples to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns.

Secondary Outcome Measures

Building new therapeutic hypotheses
To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).
Patients' prognosis determination
To evaluate the prognostic relevance of genomic alterations detected in tumor metastatic biopsies and archived primary tissue
Identification of "exceptional responders" and "rapid progressors"; the outlier patients
To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomics data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol)
Feasibility of implementing a global molecular screening platform for MBC
To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC
Correlation between molecular alterations and standardly assessed efficacy endpoints
To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival) set forth in clinical study protocols.
Patient identification to match with biomarker-driven clinical trials
To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.

Full Information

First Posted
March 19, 2014
Last Updated
January 17, 2023
Sponsor
Breast International Group
Collaborators
Breast European Adjuvant Studies Team, Frontier Science & Technology Research Foundation, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02102165
Brief Title
AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
Acronym
AURORA
Official Title
AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
suspended temporarily - amending protocol
Study Start Date
April 2014 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breast International Group
Collaborators
Breast European Adjuvant Studies Team, Frontier Science & Technology Research Foundation, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Aurora, breast cancer, metastatic, molecular screening, targeted gene sequencing, molecular aberrations, exploratory, biomarker

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metastatic lesion biopsy
Arm Type
Experimental
Arm Description
biopsy of metastatic lesion will be performed at program inclusion or maximum 6 months prior to inclusion. Sample of primary tumor must be available at inclusion.
Intervention Type
Procedure
Intervention Name(s)
metastatic lesion biopsy
Intervention Description
a medical test commonly performed by a surgeon or an interventional radiologist in order to collect tissues for examination; in this case from a metastatic lesion
Primary Outcome Measure Information:
Title
Metastatic Breast Cancer (MBC) understanding
Description
To improve the understanding of MBC by performing high coverage Targeted Gene Sequencing (TGS) and RNA sequencing on matched primary and metastatic samples to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns.
Time Frame
1 year after end of acrrual
Secondary Outcome Measure Information:
Title
Building new therapeutic hypotheses
Description
To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).
Time Frame
1 year after end of accrual and subsequently during follow up period of 10 years
Title
Patients' prognosis determination
Description
To evaluate the prognostic relevance of genomic alterations detected in tumor metastatic biopsies and archived primary tissue
Time Frame
1 year after end of accrual and subsequently during follow up period of 10 years
Title
Identification of "exceptional responders" and "rapid progressors"; the outlier patients
Description
To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomics data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol)
Time Frame
1 year after end of accrual and subsequently during follow up period of 10 years
Title
Feasibility of implementing a global molecular screening platform for MBC
Description
To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC
Time Frame
1 year after end of accrual
Title
Correlation between molecular alterations and standardly assessed efficacy endpoints
Description
To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival) set forth in clinical study protocols.
Time Frame
1 year after end of accrual and subsequently during follow up period of 10 years
Title
Patient identification to match with biomarker-driven clinical trials
Description
To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.
Time Frame
on ongoing basis during 3 years' patient recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women or men with metastatic or locally relapsed breast cancer manageable with systemic therapy Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Written informed consent prior to enrollment into the program. Patient aged ≥ 18 years Patient agrees to provide archived primary tumor tissue Patient agrees to provide newly collected metastatic lesions tissue samples (archived material up to 6 months is allowed provided both Formalin Fixed Paraffin Embedded (FFPE) block and Frozen Tissue are available and were collected from the same lesion at the same time) Patient agrees to provide blood samples Exclusion Criteria: The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy Patients with bone-only metastatic disease Patients with brain-only metastatic disease, unless surgical excision is planned (in which case tissue will be collected for AURORA purpose) Known presence of severe hematopoietic, renal, and/or hepatic dysfunction (according to the local PI) Platelet count<100 000/mm3, INR>1.5 (international normalized ratio; blood clotting time) , Albumin<30 Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin Any anti-VEGF (vascular endothelial growth factor) or anti-VEGFR (vascular endothelial growth factor receptor) treatment administered less than 4 weeks before new biopsy procedure or no appropriate wash-out period for patients on anticoagulation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Aftimos, MD
Organizational Affiliation
Institut Jules Bordet, Brussels, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mafalda Oliveira, MD
Organizational Affiliation
University Hospital Vall d'Hebron,Barcelona, Catalonia, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZA, Antwerp University Hospital
City
Edegem
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Luisenkrankenhaus
City
Düsseldorf
ZIP/Postal Code
40235
Country
Germany
Facility Name
Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
University Medical Center Freiburg
City
Freiburg
Country
Germany
Facility Name
University of Schleswig-Holstein / Campus Luebeck
City
Luebeck
Country
Germany
Facility Name
Sana Klinikum Offenbach
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Klinikum Oldenburg gGmbH
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Landspitali
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland
Facility Name
Ospedale degli Infermi - S.O.C.Oncologia
City
Biella
Country
Italy
Facility Name
Ospedale di Bolzano - Oncologia Medica
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Ospedale Ramazzini di Carpi
City
Carpi
Country
Italy
Facility Name
Az. Istituti Ospitalieri di Cremona
City
Cremona
Country
Italy
Facility Name
IRCCS AOU San Martino-IST
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ULSS 21 Legnago
City
Legnago
ZIP/Postal Code
37045
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
UOC Oncologia Medica - AOU Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
Country
Italy
Facility Name
IRCCS Az Ospedaliera S.Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Centre Hospitalier
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
City
Warsaw
Country
Poland
Facility Name
Champalimaud Foundation
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Dr Rosell Oncology Institute, Quirón Dexeus University Hospital
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Consorcio Hospitalario Provincial de Castellón
City
Castellón
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campa
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Ryhov County Hospital
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Kantonsspital Baden
City
Baden
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
Country
Switzerland
Facility Name
Luzerner Kantonsspital, Division of Medical Oncology
City
Lucerne
ZIP/Postal Code
6003
Country
Switzerland
Facility Name
Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
City
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
NHS Tayside, Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre - Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Facility Name
Nottingham University Hospital NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Velindre NHS Trust
City
South Glamorgan
ZIP/Postal Code
CF15 7QZ
Country
United Kingdom
Facility Name
Singleton Hospital - ABM University Health Board
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Yeovil District Hospital NHS Foundation Trust
City
Yeovil, Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bigagainstbreastcancer.org
Description
sponsor's website

Learn more about this trial

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

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