Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007743

Trial Description

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Title

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

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Trial Acronym

AURORA

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007743
  •   2015/02/02
  •   2014/03/19
  •   yes
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Secondary IDs

  •   NCT02102165  (ClinicalTrials.gov)
  •   BIG 14-01  (Breast International Group)
  •   1408-BCG 
  •   GBG 85 
  •   ICR-CTSU/2014/10050 
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Health Condition or Problem studied

  •   Metastatic Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Procedure: metastatic lesion biopsy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
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Primary Outcome

- Metastatic Breast Cancer (MBC) understanding; time frame: 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.

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Secondary Outcome

- 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).
- 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 tumor metastatic biopsies and archived primary tissue
- 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 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; 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
- 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) set forth in clinical study protocols.
- 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.

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Countries of Recruitment

  •   Belgium
  •   Luxembourg
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Locations of Recruitment

  • [---]*
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Recruitment

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  •   2014/04/30
  •   1300
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Breast International Group
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    • Breast European Adjuvant Studies Team
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    • Frontier Science
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    • Institut Jules Bordet, Brussels, Belgium
    • Martine Piccart, MD, PhD 
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    • Kristel Engelen, PT 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2015/01/22
* This entry means the parameter is not applicable or has not been set.