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JOURNAL ONKOLOGIE – STUDIE
AURORA

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

Rekrutierend

NCT-Nummer:
NCT02102165

Studienbeginn:
April 2014

Letztes Update:
24.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Breast International Group

Collaborator:
Jules Bordet Institute, Frontier Science & Technology Research Foundation, Inc.,

Studienleiter

Philippe Aftimos, MD
Principal Investigator
Institut Jules Bordet, Brussels, Belgium
Angel Guerrero Zotano, MD
Principal Investigator
Instituto Valenciano de Oncologia, Valencia, Spain
Matteo Benelli, PhD
Principal Investigator
Breast International Group

Kontakt

Studienlocations
(3 von 52)

Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum
45136 Essen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Frauenkliniken Maistrasse-Innenstadt und Großhadern
80336 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Cliniques Universitaires St-Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps
Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)
5000 Namur
BelgiumRekrutierend» Google-Maps
Ospedale degli Infermi - S.O.C.Oncologia
Biella
ItalyAktiv, nicht rekrutierend» Google-Maps
Ospedale di Bolzano - Oncologia Medica
39100 Bolzano
ItalyAktiv, nicht rekrutierend» Google-Maps
Ospedale Ramazzini di Carpi
Carpi
ItalyAktiv, nicht rekrutierend» Google-Maps
IRCCS AOU San Martino-IST
16132 Genova
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Europeo di Oncologia
20141 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
UOC Oncologia Medica - AOU Parma
43126 Parma
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione Salvatore Maugeri
Pavia
ItalyAktiv, nicht rekrutierend» Google-Maps
IRCCS Az Ospedaliera S.Maria Nuova
Reggio Emilia
ItalyAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier
1210 Luxembourg
LuxembourgAktiv, nicht rekrutierend» Google-Maps
Complexo Hospitalario Universitario A Coruña
15006 A Coruña
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital del Mar
08003 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Dr Rosell Oncology Institute, Quirón Dexeus University Hospital
08028 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Vall d'Hebron
08035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Consorcio Hospitalario Provincial de Castellón
12002 Castellón De La Plana
SpainAbgeschlossen» Google-Maps
Hospital San Pedro de Alcantara
10003 Cáceres
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari Arnau de Vilanova
25198 Lleida
SpainAktiv, nicht rekrutierend» Google-Maps
MD Anderson Cancer Center
28033 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clínico San Carlos
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Centro Integral Oncológico Clara Campa
28050 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainAbgeschlossen» Google-Maps
Instituto Valenciano de Oncología
46009 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital General Universitario de Valencia
46014 Valencia
SpainAbgeschlossen» Google-Maps
Sahlgrenska University Hospital
Gothenburg
SwedenAktiv, nicht rekrutierend» Google-Maps
Ryhov County Hospital
55185 Jönköping
SwedenAktiv, nicht rekrutierend» Google-Maps
Luzerner Kantonsspital, Division of Medical Oncology
6003 Lucerne
SwitzerlandAbgeschlossen» Google-Maps
Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
B15 2TH Birmingham
United KingdomAktiv, nicht rekrutierend» Google-Maps
University Hospitals Bristol NHS Foundation Trust
BS2 8HW Bristol
United KingdomAktiv, nicht rekrutierend» Google-Maps
Velindre NHS Trust
CF15 7QZ Cardiff
United KingdomAktiv, nicht rekrutierend» Google-Maps
NHS Tayside, Ninewells Hospital
DD1 9SY Dundee
United KingdomAktiv, nicht rekrutierend» Google-Maps
Edinburgh Cancer Centre - Western General Hospital
EH4 2XU Edinburgh
United KingdomAktiv, nicht rekrutierend» Google-Maps
Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomAktiv, nicht rekrutierend» Google-Maps
Christie NHS Foundation Trust
Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Nottingham University Hospital NHS Trust
Nottingham
United KingdomAktiv, nicht rekrutierend» Google-Maps
Singleton Hospital - ABM University Health Board
SA2 8QA Swansea
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
TR1 3LJ Truro
United KingdomAktiv, nicht rekrutierend» Google-Maps
Yeovil District Hospital NHS Foundation Trust
BA21 4AT Yeovil
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Female or male ≥ 18 years with diagnosis of locally recurrent/advanced BC not amenable

to treatment with curative intent or MBC who have not received more than 1 line of

systemic therapy (any type) in the metastatic setting.

Under protocol 4.0, eligible patients will be limited to locally recurrent/advanced

breast cancer not amenable to treatment with curative intent or MBC with:

- histopathology-confirmed TNBC as defined by ER <1% and HER2 negative following

ASCO-CAP guidelines

- ILC (either based on ILC morphology or negative E-cadherin expression confirmed

by IHC). Mixed ILC/invasive ductal carcinoma are not eligible for the ILC cohort.

- late relapse BC (any subtype). Late relapse is defined as a patient with a

radiologic or histologic confirmation of advanced or MBC relapse > 10 years from

the primary BC diagnosis.

2. Written informed consent prior to registration into the program.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

4. Availability of primary tumor tissue for research purposes.

5. Patient must have a metastatic lesion accessible for biopsy and must agree with the

biopsy procedure.

1. Up until protocol 3.0, up to 100 patients with bone-only metastasis have been

included without a metastatic biopsy, if plasma samples have been collected at

screening, and if the patient met all other eligibility criteria.

2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted

provided that the chosen site of biopsy was not previously irradiated.

3. Brain tissue is accepted if it is obtained through surgical excision not planned

for AURORA, but as part of the routine clinical practice.

6. The biopsy of the metastatic lesion must be conducted either at the initial diagnosis

of the BC relapse before the initiation of 1st line systemic therapy or at the 1st

disease progression before initiation of a second line systemic treatment. There is no

restriction in the type of therapeutic modality considered as 1st line systemic

treatment, which can consist of any type of treatment administered after the diagnosis

of the advanced BC relapse till the 1st disease progression thereafter.

7. Biopsies obtained during routine clinical practice are accepted if both formalin-fixed

paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently

from the same metastatic lesion and if collected at the pre-specified timelines for

AURORA.

8. Availability of a whole blood, serum and plasma samples collected at the time of

screening.

9. Patient agrees to provide blood samples at regular intervals, from the screening as

well as during the follow-up phase of the program.

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. Presence of severe hematopoietic, renal, and/or hepatic dysfunction, including but not

restricted to albumin < 3 g/dl.

4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the

treating physician.

5. 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.

Studien-Rationale

Primary outcome:

1. Metastatic Breast Cancer (MBC) understanding (Time Frame - 1 year after end of acrrual):
To improve the understanding of locally recurrent/advanced BC and MBC by using high-throughput technologies on primary, metastatic, as well as plasma ctDNA samples, to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns.



Secondary outcome:

1. Identification of "exceptional responders" and "rapid progressors"; the outlier patients (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years):
To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomic data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol).

2. Feasibility of implementing a global molecular screening platform for MBC (Time Frame - 1 year after end of accrual):
To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC

3. Patient identification to match with biomarker-driven clinical trials (Time Frame - on ongoing basis during 3 years' patient recruitment):
To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.

4. Building new therapeutic hypotheses (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years):
To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).

5. Patients' prognosis determination (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years):
To evaluate the prognostic relevance of genomic alterations detected in plasma ctDNA samples, tumor metastatic biopsies and archived primary tissue.

6. Correlation between molecular alterations and standardly assessed efficacy endpoints (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years):
To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival).

Geprüfte Regime

  • metastatic lesion biopsy:
    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

Quelle: ClinicalTrials.gov


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