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

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT07084571
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 24, 2025
Start date
Feb 23, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2040
Completion
Apr 30, 2040

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Proportion of patients having two or more tumour sites sampled in one procedural sitting when technically feasible [ Time Frame: Through study completion, 15 years ]

Central Contacts

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