Observational study on mechanobiology in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

METAMECH is an observational protocol designed to enhance collaboration between basic and clinical research in breast cancer. It will follow a cohort of at least 500 patients over their treatment journey, collecting longitudinal clinical data and samples. The study aims to understand the interactions between tumor and host cells to improve patient outcomes, including reducing recurrence rates and enhancing survival. Patients will be enrolled at two therapeutic checkpoints: before tumor sampling or before starting any treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione IRCCS, Istituto Nazionale dei Tumori
  Milan, Milan, Italy Recruiting
• Fondazione IRCCS, Istituto Neurologico Carlo Besta
  Milan, Milan, Italy Recruiting
• Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
  Novara, Novara, Italy Recruiting
• Istituto Oncologico Veneto IRCCS (IOV)
  Padova, Padova, Italy Recruiting
• Fondazione IRCCS, Policlinico San Matteo Pavia
  Pavia, Pavia, Italy Recruiting
• Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO)
  Roma, Roma, Italy Recruiting

Study contacts

• Study coordinator: Smeralda Rapisarda
• Email: clinical.trials@ifom.eu
• Phone: +3902574303236

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.