A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer

Breast Cancer Clinical Trial

— METAMECH  

Official title:

A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625023
• Other study ID #: IFOM-CPO007/2019/PO006
• Status: Recruiting
• Start date: July 16, 2020
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: IFOM ETS - The AIRC Institute of Molecular Oncology
• Contact: Luca Lazzari, PhD
• Phone: +3902574303799
• Email: clinical.trials[@]ifom.eu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Observational
Retrospective cohorts and Prospective observation of standard clinical practice

Locations

Country	Name	City	State
Italy	Asst Papa Giovanni Xxiii	Bergamo
Italy	Fondazione IRCCS, Istituto Nazionale dei Tumori	Milan
Italy	Fondazione IRCCS, Istituto Neurologico Carlo Besta	Milan
Italy	Azienda Ospedaliero Universitaria Maggiore della Carità di Novara	Novara
Italy	Istituto Oncologico Veneto IRCCS (IOV)	Padova
Italy	Fondazione IRCCS, Policlinico San Matteo Pavia	Pavia
Italy	Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO)	Roma

Sponsors (1)

Lead Sponsor	Collaborator
IFOM ETS - The AIRC Institute of Molecular Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New prognostic mechanotransduction-linked markers	Number of identified/validated new prognostic mechanotransduction-linked markers	6 months
Other	New predictive mechanotransduction-linked markers	Number of identified/validated new predictive mechanotransduction-linked markers	6 months
Other	Biomarkers correlation with RR	Correlation between identified biomarkers with therapies response rates (RR)	6 months
Other	Biomarkers correlation with PFS	Correlation between identified biomarkers with progression-free survival (PFS)	6 months
Other	Biomarkers correlation with OS	Correlation between identified biomarkers with overall survival (OS)	6 months
Primary	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	6 months
Primary	Number of patients recruited in TIER2	Number of recruited BC cases in TIER 2	6 months
Secondary	Number of patients triaged in proof-of concept (POC) clinical trials	Number of BC cases recruited in TIER 3	6 months