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

• Sponsor: Breast International Group (Other)
• Overall Status: Suspended
• CT.gov ID: NCT02102165
• Collaborator: Breast European Adjuvant Studies Team (Other), Frontier Science & Technology Research Foundation, Inc. (Industry)
• Enrollment: 1,000
• Locations: 60
• Arm: 1
• Anticipated Duration (Months): 203
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Procedure: metastatic lesion biopsy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.
• Actual Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metastatic lesion biopsy 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.	Procedure: 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

Outcome Measures

Primary Outcome Measures

1. Metastatic Breast Cancer (MBC) understanding [1 year after end of acrrual]

   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

1. Building new therapeutic hypotheses [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).

2. Patients' prognosis determination [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 tumor metastatic biopsies and archived primary tissue

3. Identification of "exceptional responders" and "rapid progressors"; the outlier patients [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 transcriptomics data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol)

4. Feasibility of implementing a global molecular screening platform for MBC [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

5. Correlation between molecular alterations and standardly assessed efficacy endpoints [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) set forth in clinical study protocols.

6. Patient identification to match with biomarker-driven clinical trials [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jules Bordet	Brussels		Belgium	1000
2	Cliniques Universitaires St-Luc	Brussels		Belgium	1200
3	Grand Hopital Charleroi	Charleroi		Belgium	6000
4	UZA, Antwerp University Hospital	Edegem		Belgium	1000
5	UZ Leuven	Leuven		Belgium	3000
6	CHU de Liège	Liège		Belgium	4000
7	Clinique et Maternité Sainte-Elisabeth (CMSE - Namur)	Namur		Belgium	5000
8	Sint-Augustinus	Wilrijk		Belgium	2610
9	Luisenkrankenhaus	Düsseldorf		Germany	40235
10	Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum	Essen		Germany	45136
11	University Medical Center Freiburg	Freiburg		Germany
12	University of Schleswig-Holstein / Campus Luebeck	Luebeck		Germany
13	Sana Klinikum Offenbach	Offenbach		Germany	63069
14	Klinikum Oldenburg gGmbH	Oldenburg		Germany	26133
15	Landspitali	Reykjavík		Iceland	101
16	Ospedale degli Infermi - S.O.C.Oncologia	Biella		Italy
17	Ospedale di Bolzano - Oncologia Medica	Bolzano		Italy	39100
18	Ospedale Ramazzini di Carpi	Carpi		Italy
19	Az. Istituti Ospitalieri di Cremona	Cremona		Italy
20	IRCCS AOU San Martino-IST	Genova		Italy	16132
21	ULSS 21 Legnago	Legnago		Italy	37045
22	Istituto Europeo di Oncologia	Milano		Italy	20141
23	UOC Oncologia Medica - AOU Parma	Parma		Italy	43126
24	Fondazione Salvatore Maugeri	Pavia		Italy
25	IRCCS Az Ospedaliera S.Maria Nuova	Reggio Emilia		Italy
26	Centre Hospitalier	Luxembourg		Luxembourg	1210
27	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Warsaw		Poland
28	Champalimaud Foundation	Lisboa		Portugal	1400-038
29	Complexo Hospitalario Universitario A Coruña	A Coruña		Spain	15006
30	Hospital del Mar	Barcelona		Spain	08003
31	Dr Rosell Oncology Institute, Quirón Dexeus University Hospital	Barcelona		Spain	08028
32	Hospital Vall d'Hebron	Barcelona		Spain	08035
33	Consorcio Hospitalario Provincial de Castellón	Castellón		Spain	12002
34	Hospital San Pedro de Alcantara	Cáceres		Spain	10003
35	Hospital Universitari Arnau de Vilanova	Lleida		Spain	25198
36	MD Anderson Cancer Center	Madrid		Spain	28033
37	Hospital Clínico San Carlos	Madrid		Spain	28040
38	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
39	Centro Integral Oncológico Clara Campa	Madrid		Spain	28050
40	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
41	Instituto Valenciano de Oncología	Valencia		Spain	46009
42	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
43	Hospital General Universitario de Valencia	Valencia		Spain	46014
44	Sahlgrenska University Hospital	Gothenburg		Sweden
45	Ryhov County Hospital	Jönköping		Sweden	55185
46	Kantonsspital Baden	Baden		Switzerland
47	Inselspital Bern	Bern		Switzerland
48	Kantonsspital Graubuenden	Chur		Switzerland
49	Luzerner Kantonsspital, Division of Medical Oncology	Lucerne		Switzerland	6003
50	Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust	Birmingham		United Kingdom	B15 2TH
51	University Hospitals Bristol NHS Foundation Trust	Bristol		United Kingdom	BS2 8HW
52	Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust	Cornwall		United Kingdom	TR1 3LJ
53	NHS Tayside, Ninewells Hospital	Dundee		United Kingdom	DD1 9SY
54	Edinburgh Cancer Centre - Western General Hospital	Edinburgh		United Kingdom	EH4 2XU
55	Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YN
56	Christie NHS Foundation Trust	Manchester		United Kingdom
57	Nottingham University Hospital NHS Trust	Nottingham		United Kingdom
58	Velindre NHS Trust	South Glamorgan		United Kingdom	CF15 7QZ
59	Singleton Hospital - ABM University Health Board	Swansea		United Kingdom	SA2 8QA
60	Yeovil District Hospital NHS Foundation Trust	Yeovil, Somerset		United Kingdom	BA21 4AT

Sponsors and Collaborators

• Breast International Group
• Breast European Adjuvant Studies Team
• Frontier Science & Technology Research Foundation, Inc.

Investigators

• Principal Investigator: Philippe Aftimos, MD, Institut Jules Bordet, Brussels, Belgium
• Principal Investigator: Mafalda Oliveira, MD, University Hospital Vall d'Hebron,Barcelona, Catalonia, Spain

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• sponsor's website

Publications

None provided.

• Responsible Party: Breast International Group
• ClinicalTrials.gov Identifier: NCT02102165
• Other Study ID Numbers: BIG 14-01; 1408-BCG; GBG 85; ICR-CTSU/2014/10050
• First Posted: Apr 2, 2014
• Last Update Posted: Jul 8, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Breast International Group: Aurora; breast cancer; metastatic; molecular screening; targeted gene sequencing; molecular aberrations; exploratory; biomarker
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 8, 2021