Breast CancerESCATNCT06958224
Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers
A study testing Large and early multigene sequencing in people with Breast Cancer and Liver Cancer, run by University Hospital, Lille at 1 site in France.
Trial summary
The European Society for Medical Oncology (ESMO) strongly recommends to develop multigene sequencing in the framework of molecular screening programmes, in order to improve access to innovative drugs and to accelerate clinical research in cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Liver Cancer, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Large and early multigene sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2026to 9 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age >18 years.
- Advanced disease status ("unresectable" or "metastatic").
- Patient included either at the time of diagnostic investigation or during first line of treatment.
- Good general conditions, still compatible with a therapeutic proposal, WHO 0-1.
- The following tumour sites, with poor prognosis and for which ESCAT II/IV treatment targets can be found according to ESMO:
- pancreatic adenocarcinoma
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- hepatocellular carcinomas,
- triple negative breast cancer.
- Tumour tissue a priori available in sufficient quantity: at least one biopsy from a visceral metastatic site or surgical specimen (if available) for eligible cancers.
- Patient covered by a social sercurity scheme
Who cannot join
- - General condition WHO >1 and/or nutritional status not compatible with a therapeutic proposal
- Limiting systemic cardiovascular, renal, bronchopulmonary or endocrinological comorbidities with the initiation of a therapeutic proposal
- Active infection or active chronic disease (diabetes, liver dysfunction, immune disease) making the patient's condition incompatible with a therapeutic proposal.
- A priori unavailable, in insufficient quantity or of suboptimal quality tumour material.
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez - Service Oncologie
Lille, 59000
Anthony TURPIN, Pr, 03.20.44.54.61, anthony.turpin@chu-lille.fr
About this study
Official title: Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers, Not Eligible for Initial Sequencing in Clinical Routine and Selected From the First Line in Molecular Tumour Board.
The European Society for Medical Oncology (ESMO) strongly recommends to develop multigene sequencing in the framework of molecular screening programmes, in order to improve access to innovative drugs and to accelerate clinical research in cancers.
- Accordingly, this project aims to study the contribution of early systematic multigene sequencing (NGS) discussed in Molecular Tumour Board for poor prognosis cancers, with no current indication for early sequencing.
- The investigators teams propose to perform a randomized study in tumours in which actionable therapeutic targets according to the ESMO ESCAT scale are known (ESCAT II/IV) especially in pancreatic ductal adenocarcinoma, hepatocellular carcinoma or triple negative breast cancer.
Read more
Two approaches will be compared: a large multigenic early sequencing approach since the first line setting versus a Plan France Medecine Genomique 2025 approach since the second line setting.
The frequency of really initiated therapeutic proposals according to the molecular status will be compared in each group.
Read the detailed description
Part 1 sequential multi-gene sequencing (Simple NGS),
- Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations)
- And if no contributive:
Part 2: randomized study between two sequential approaches
- Experimental arm: early Multi-gene DNA sequencing (638 genes panel) Multi-gene RNA sequencing (ARCHER panel)
- MMR status in molecular biology
- - Tumour Mutational Burden
- Control arm: after 1st line escape, according to Plan France Medecine Genomique 2025 In the Part 2, a new biopsy could be proposed if necessary
- Being tested
- Large and early multigene sequencing
- Keywords
- Poor prognosis cancers, Multi-gene sequencing, Molecular Tumour Board, Personalized medicine, Clinical trials
- Medical subject headings
- Breast Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large and early multigene sequencingGenetic
Part 1 sequential multi-gene sequencing (Simple NGS),
- Multi-gene DNA sequencing (43 genes panel corresponding to the most frequently targeted molecular alterations)
- And if no contributive:
Part 2: randomized study between two sequential approaches
- Experimental arm: early Multi-gene DNA sequencing (638 genes panel) Multi-gene RNA sequencing (ARCHER panel)
- MMR status in molecular biology
- - Tumour Mutational Burden
- Control arm: after 1st line escape, according to Plan France Medecine Genomique 2025 In the Part 2, a new biopsy could be proposed if necessary
| Study group | Role | What they receive |
|---|---|---|
| Large and early multigene sequencing | Experimental | Not described Receives: Genetic: Large and early multigene sequencing |
| Large Sequential multigene sequencing according to Plan France Medecine Genomique 2025 | Active comparator | Not described Receives: Genetic: Large and early multigene sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients receiving a proposal for treatment leading to effective initiation of treatment.
Measured: Within 2 years of the first Molecular Tumour Board.
Secondary outcomes (5)
1. Frequency of therapeutic proposals, whether or not leading to treatment, among patients with at least one molecular alteration found
Measured: Within 2 years of the first Molecular Tumour Board.
2. The number of potentially targetable molecular alterations found.
Measured: Within 2 years of the first Molecular Tumour Board.
The frequency of the types of potentially targetable molecular alterations found according to the ESCAT classification (ESCAT I / II / III / IV).
Measured: Within 2 years of the first Molecular Tumour Board.
4. Frequency of types of therapeutic proposals (clinical trials, off-label targeted therapies).
Measured: Within 2 years of the first Molecular Tumour Board.
Time to treatment proposal, defined as the time between the date of the first Molecular Tumour Board and the treatment proposal following the second Molecular Tumour Board.
Measured: Within 2 years of the first Molecular Tumour Board.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start29 Apr 2026
- Primary completion10 Nov 2028 (estimated)
- Study completion9 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958224
- Sponsor's protocol ID
- 2023_0285
- Acronym
- ESCAT
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No