Actively Recruiting

Age: 18Years +
All Genders
NCT07084571

Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution

Led by Royal Marsden NHS Foundation Trust · Updated on 2026-03-12

200

Participants Needed

1

Research Sites

735 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

FORTITUDE is a translational research study that aims to collect serial multi-site needle biopsy samples of tumour tissue and blood from metastatic breast cancer patients. Cancer biopsies are generally performed when cancer is diagnosed and are sometimes repeated when the cancer is suspected to have spread but this is not mandatory. However, studies have shown that cancers change with time and evolve to become resistant to therapy. The purpose of this study is to assess the feasibility of biopsies of multiple cancer sites across different time points during treatment and understand how cancers evolve and change throughout treatment. The findings of this study could pave the way for using cancer biopsies more frequently in the clinic to pick up changes in cancer behaviour that could influence treatment choice. The samples collected from this study will be used for molecular and genetic research to increase our understanding of how metastatic breast cancer changes during treatment and will enable us to develop new cancer treatments and new ways of monitoring response to cancer therapies.

CONDITIONS

Official Title

Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed locally advanced, inoperable breast cancer or metastatic breast cancer OR radiological evidence of metastatic disease strongly suspected to be recurrence of previously diagnosed breast cancer
  • Age 18 years or older
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Metastatic disease limited only to bones without any soft tissue involvement
  • Bleeding disorders or anticoagulation that cannot be corrected making biopsy risk unacceptable
  • Significant biopsy risk greater than 1% as assessed by physician
  • Eastern Cooperative Oncology Group performance status of 3 or higher
  • Known chronic infectious diseases such as Hepatitis B, Hepatitis C, or HIV that may affect safety
  • Psychological, familial, or social conditions that may interfere with study compliance and follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Actively Recruiting

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Research Team

S

Sophie Cooke

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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