Repeated biopsies of breast cancer sites to study how the cancer changes
Tests repeated needle biopsies of several tumour sites in adults with metastatic breast cancer.
Plain-language title generated from the registry record
Registry title: Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution
Key facts
- Where
- London, United KingdomSee the site
Where in United Kingdom
- Royal Marsden NHS Foundation TrustLondon, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Royal Marsden NHS Foundation Trust
- Trial code
- NCT07084571
- Record updated
- 12 March 2026
- Original description
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.Read full original descriptionShow less
Feasibility of Serial Multisite Image-Guided Biopsy To Study Breast Cancer Evolution
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.
Inclusion: Histologically confirmed locally advanced, inoperable breast cancer or metastatic breast cancer OR radiological evidence of metastatic disease with a high index of suspicion that this is a recurrence of a previously diagnosed breast cancer; Be aged 18 years and over; Have given written informed consent to participate.
Exclusion: Metastatic disease limited to bones, without a soft tissue component; Any bleeding disorders or anticoagulation that cannot be corrected and that would render the risk of biopsy unacceptable; Known chronic infectious disease (Hepatitis B and C, HIV) that may impact patient safety; Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule; If the consultant physician involved in the care of the patient assesses and decides the risk of the biopsy procedures is significant, defined as greater than 1% risk of significant complication; Eastern Cooperative Oncology Group performance status of 3 and higher.