A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer (METAMECH)

April 29, 2025 updated by: IFOM ETS - The AIRC Institute of Molecular Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Asst Papa Giovanni Xxiii
        • Principal Investigator:
          • Vittoria Fotia, MD
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS, Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Filippo De Braud, MD
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS, Istituto Neurologico Carlo Besta
        • Principal Investigator:
          • Cecilia Casali, MD
      • Milano, Italy, 20089
        • Recruiting
        • IRCCS Humanitas
        • Principal Investigator:
          • Alberto Zambelli, MD
      • Milano, Italy, 20141
        • Recruiting
        • IEO - Istituto Europeo di Oncologia
        • Principal Investigator:
          • Viviana Galimberti
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
        • Principal Investigator:
          • Alessandra Gennari, MD
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS (IOV)
        • Principal Investigator:
          • Valentina Guarneri, MD
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS, Policlinico San Matteo Pavia
        • Principal Investigator:
          • Paolo Pedrazzoli, MD
      • Reggio Emilia, Italy, 42122
        • Recruiting
        • Azienda U.S.L. - IRCCS di Reggio Emilia
        • Principal Investigator:
          • Filippo Giovanardi, MD
      • Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO)
        • Principal Investigator:
          • Giovanni Blandino, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stage-mixed Breast Cancer (BC) patients

Description

Inclusion Criteria:

  1. Verification that the patient could not be reached for informed consent in accordance with applicable national regulations or, alternatively, TIER1 written Informed consent.
  2. Patients ≥18 years of age.
  3. Previous diagnosis of breast cancer, or a strong suspicion of BC based on clinical and radiological findings.
  4. ECOG Performance status < 2 (only for TIER1-2).

Exclusion Criteria:

  1. 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)
  2. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
  3. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Observational
Retrospective cohorts and Prospective observation of standard clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Number of patients recruited in TIER2
Time Frame: 6 months
Number of recruited BC cases in TIER 2
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients triaged in proof-of concept (POC) clinical trials
Time Frame: 6 months
Number of BC cases recruited in TIER 3
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
New prognostic mechanotransduction-linked markers
Time Frame: 6 months
Number of identified/validated new prognostic mechanotransduction-linked markers
6 months
New predictive mechanotransduction-linked markers
Time Frame: 6 months
Number of identified/validated new predictive mechanotransduction-linked markers
6 months
Biomarkers correlation with RR
Time Frame: 6 months
Correlation between identified biomarkers with therapies response rates (RR)
6 months
Biomarkers correlation with PFS
Time Frame: 6 months
Correlation between identified biomarkers with progression-free survival (PFS)
6 months
Biomarkers correlation with OS
Time Frame: 6 months
Correlation between identified biomarkers with overall survival (OS)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IFOM ETS - The AIRC Institute of Molecular Oncology

Investigators

  • Study Chair: Silvia Marsoni, MD, IFOM ETS - The AIRC Institute of Molecular Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFOM-CPO007/2019/PO006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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