Breast Cancer, Omics, and Precision Medicine
BR(E)2ASTOME
Evaluating the Predictive and Prognostic Power of the Early Breast canceR gEnetic and Epigenetic Abnormalities Through Liquid biopSy and neTwOrk MEdicine Algorithm: the BR(E)2ASTOME Phase II Randomized Controlled Trial
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
The standard tissue biopsy strategy for cancer detection is not comprehensive enough to profile the whole epi-genomic signatures of breast cancer (BC) and ensure an accurate prognosis and prediction of drug response. Liquid-based assays have the potential to reduce the molecular heterogeneity of BC and a possible utility for improving disease management. In particular, genomic DNA (gDNA) and circulating tumor (ctDNA) can be sequenced for genetic and epigenetic (DNA methylation) profiling of the BC patients to enhance personalized prognosis and prediction of drug therapy. We describe a study protocol for evaluating the clinical utility of the early use of the network-oriented BR(E)2ASTOME algorithm which combine the power of liquid-based assays, advanced epi-genomics platform, and network analysis to identify improve precision medicine and personalized therapy of BC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2022
Shorter than P25 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 13, 2021
August 1, 2021
11 months
August 2, 2021
August 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of Network-oriented buomarkers in prognosis of BC
We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for a better stratification of BC severity. We will measure: DNA methylation levels and associations with clinical parameters (survival, hospitalization, all-cause mortality). We will evaluate potential novel genetic mutations in targeted genes and associations with clinical parameters (survival, rate of hospitalization, all-cause mortality)
1 years
Evaluation of Network-oriented buomarkers of Drug Response
We will evaluate whether the network-oriented BR(E)2ASTOME approach will identify BC modules useful for predicting the individual drug response. We will measure DNA methylation levels, and potential novel genetic mutations, and their association with clinical parameters (poor/good response to drug therapy).
2 years
Study Arms (2)
BC diagnosis and Omics
EXPERIMENTALParticipants will be offered: 1. Liquid biopsy of ctDNA and targeted NGS (BRCA1, BRCA2, CHEK2, PALB2, BRIP1, TP53, PTEN, STK11, CDH1, ATM, BARD1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, PMS1, PMS2, RAD50, RAD51C, RAD51D, NF1, EPCAM, SMARCA4, CDK12); 2. Whole-genome RRBS
BC diagnosis and standard of the care
NO INTERVENTIONParticipants will not be offered targeted NGS or whole-genome RRBS but will receive their usual clinical care
Interventions
Next Generation Sequencing and Network Analysis will profile genetic and epigenetic abnormalities in blood from patients with BC.
Eligibility Criteria
You may qualify if:
- Sporadic BC
- Inherited BC
- years old
- Males and Females
You may not qualify if:
- Inflammatory diseases
- Cardiovascular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 9, 2021
Study Start
January 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share