Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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

metastatic lesion biopsy

AURORA BIG HQ

Philippe Aftimos, MD

Angel Guerrero Zotano, MD

Matteo Benelli, PhD

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.

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

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.

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).

To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC

To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.

To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).

To evaluate the prognostic relevance of genomic alterations detected in plasma ctDNA samples, tumor metastatic biopsies and archived primary tissue.

To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival).

Jules Bordet Institute

Frontier Science & Technology Research Foundation, Inc.

Breast International Group

All Drugs and Chemicals

Hormones

Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.

detect gene mutations of ctDNA and ctRNA

Huiping Li, M.D.

Huiping LI, M.D.

Huiping Li

The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or paraffin section), and to compare the similarities and differences between the western population and Chinese population; 2) plasma samples of patients with HER2 overexpression , hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to therapeutic effect; 3) to study the specific changes of liquid molecular detection results according to the previous research results, and establish mathematical models to predict and monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide molecular detection basis for follow-up clinical research and screening for targets of new drugs.

Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China

ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.	NCT02102165	Metastatic Brea...	metastatic lesi...	18 Years -	Breast International Group
Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China	NCT03792529	Breast Cancer	detect gene mut...	18 Years - 80 Years	Peking University Cancer Hospital & Institute
Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China	NCT03792529	Breast Cancer	detect gene mut...	18 Years - 80 Years	Peking University Cancer Hospital & Institute

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