Breast CancerMETAMECHNCT04625023
A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
An observational study of Breast Cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 10 sites in Italy.
Trial summary
METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Observational
- How many people
- 1,500 participants
- Where
- 10 sitesItaly
- Study dates
- 16 Jul 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Stage-mixed Breast Cancer (BC) patients
Who may be able to join
- Verification that the patient could not be reached for informed consent in accordance with applicable national regulations or, alternatively, TIER1 written Informed consent.
- Patients ≥18 years of age.
- Previous diagnosis of breast cancer, or a strong suspicion of BC based on clinical and radiological findings.
- ECOG Performance status < 2 (only for TIER1-2).
Who cannot join
- Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Not yet recruiting
Asst Papa Giovanni Xxiii
Bergamo, Bergamo, 24127
Vittoria Fotia, MD
- Recruiting
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, Milan, 20133
Filippo De Braud, MD
- Recruiting
Fondazione IRCCS, Istituto Neurologico Carlo Besta
Milan, Milan, 20133
Cecilia Casali, MD
- Recruiting
IRCCS Humanitas
Milan, 20089
Alberto Zambelli, MD
- Recruiting
IEO - Istituto Europeo di Oncologia
Milan, 20141
Viviana Galimberti
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Novara, 28100
Alessandra Gennari, MD
- Recruiting
Istituto Oncologico Veneto IRCCS (IOV)
Padova, Padova, 35128
Valentina Guarneri, MD
- Recruiting
Fondazione IRCCS, Policlinico San Matteo Pavia
Pavia, Pavia, 27100
Paolo Pedrazzoli, MD
- Recruiting
Azienda U.S.L. - IRCCS di Reggio Emilia
Reggio Emilia, 42122
Filippo Giovanardi, MD
- Recruiting
Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO)
Roma, Roma, 00144
Giovanni Blandino, MD
About this study
METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology.
METAMECH will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, METAMECH will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials.
Read the detailed description
METAMECH has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of breast cancer (BC) patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improve). This clinical resource for integrative clinical data and sample collection will allow to generate hypotheses on mechanisms supporting the outgrowth of human metastases, mine for new potentially actionable targets and the selection of appropriate patients for experimentally-driven trials. To achieve the required level of 'experimental precision', patients will enter METAMECH at two different 'therapeutic checkpoints': i) prior to a tumor sampling event (surgery, biopsy) or ii) prior to any line of treatment.
To optimize the enrollment of patients, the longitudinal collection of data/samples and their logistic management, METAMECH has been designed as a flexible infrastructure organized in Tiers for the stepwise comprehension of the biological processes that drive tumor evolution, and precisely:
- TIER0, Retrieving: the ability to retrospectively retrieve clinically annotated BC archival samples to validate/discover new mechanotransduction-linked biomarkers;
- TIER1, Recording: the ability to prospectively record BC characteristics under standard of care treatments and to define new mechanotransduction-linked biomarkers;
- TIER2, Modelling: the ability to develop pertinent experimental models to study the aberrant mechanisms underlying the metastatic outgrowth and define mechanotransduction-targeting therapeutic strategies;
- TIER3, Linking: the ability to access data and samples of patients enrolled in POC trials to prove the efficacy and study/understand resistance mechanisms of mechanotransduction-targeting therapies.
- Conditions
- Breast Cancer
- Being tested
- Observational
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Retrospective cohorts and Prospective observation of standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Cohort of BC patients | Stage-mixed cohort of at least 1500 breast cancer patients through their course of treatment, until death or a minimum of 5 years. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients recruited in TIER0 and TIER 1
Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples
Measured: 6 months
Number of patients recruited in TIER2
Number of recruited BC cases in TIER 2
Measured: 6 months
Secondary outcomes (1)
Number of patients triaged in proof-of concept (POC) clinical trials
Number of BC cases recruited in TIER 3
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start16 Jul 2020
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Marsoni, MD, Study chair, IFOM ETS - The AIRC Institute of Molecular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625023
- Sponsor's protocol ID
- IFOM-CPO007/2019/PO006
- Acronym
- METAMECH
- Status last verified
- Sep 2024
- First submitted
- 6 Nov 2020
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
- ClinicalTrials.gov ID
- NCT04625023
- Acronym / sponsor ID
- METAMECH / IFOM-CPO007/2019/PO006
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- IFOM ETS - The AIRC Institute of Molecular OncologyUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology.
METAMECH will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, METAMECH will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials.
Detailed description
METAMECH has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of breast cancer (BC) patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improve). This clinical resource for integrative clinical data and sample collection will allow to generate hypotheses on mechanisms supporting the outgrowth of human metastases, mine for new potentially actionable targets and the selection of appropriate patients for experimentally-driven trials. To achieve the required level of 'experimental precision', patients will enter METAMECH at two different 'therapeutic checkpoints': i) prior to a tumor sampling event (surgery, biopsy) or ii) prior to any line of treatment.
To optimize the enrollment of patients, the longitudinal collection of data/samples and their logistic management, METAMECH has been designed as a flexible infrastructure organized in Tiers for the stepwise comprehension of the biological processes that drive tumor evolution, and precisely:
- TIER0, Retrieving: the ability to retrospectively retrieve clinically annotated BC archival samples to validate/discover new mechanotransduction-linked biomarkers;
- TIER1, Recording: the ability to prospectively record BC characteristics under standard of care treatments and to define new mechanotransduction-linked biomarkers;
- TIER2, Modelling: the ability to develop pertinent experimental models to study the aberrant mechanisms underlying the metastatic outgrowth and define mechanotransduction-targeting therapeutic strategies;
- TIER3, Linking: the ability to access data and samples of patients enrolled in POC trials to prove the efficacy and study/understand resistance mechanisms of mechanotransduction-targeting therapies.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of BC patients | – | Other: ObservationalStage-mixed cohort of at least 1500 breast cancer patients through their course of treatment, until death or a minimum of 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage-mixed Breast Cancer (BC) patients
Key inclusion criteria (4 listed)
- Verification that the patient could not be reached for informed consent in accordance with applicable national regulations or, alternatively, TIER1 written Informed consent.
- Patients ≥18 years of age.
- Previous diagnosis of breast cancer, or a strong suspicion of BC based on clinical and radiological findings.
- ECOG Performance status < 2 (only for TIER1-2).
Key exclusion criteria (3 listed)
- Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalRetrospective cohorts and Prospective observation of standard clinical practice | Other | Cohort of BC patients |
Primary outcome
Number of patients recruited in TIER0 and TIER 1
Time frame: 6 months
Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples
Number of patients recruited in TIER2
Time frame: 6 months
Number of recruited BC cases in TIER 2
1 secondary outcome
Number of patients triaged in proof-of concept (POC) clinical trials
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Marsoni, MD study chair
IFOM ETS - The AIRC Institute of Molecular Oncology
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by IFOM ETS - The AIRC Institute of Molecular Oncology at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smeralda Rapisarda (+3902574303236, clinical.trials@ifom.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients recruited in TIER0 and TIER 1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.