NCT07084571Recruiting
Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- Feb 2026
- Primary completion date
- Apr 2040
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- NCT number
- NCT07084571
What you commit to
- Study type: Observational
- Planned participants: 200
- From Feb 2026 to the primary completion date, Apr 2040
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.