NCT07084571 Feasibility of Serial Multisite Image-guided Biopsy to Study Breast Cancer Evolution
| NCT ID | NCT07084571 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2040-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-02-23 with a primary completion date of 2040-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Be aged 18 years and over. 3. Have given written informed consent to participate. Exclusion Criteria: 1. Metastatic disease limited to bones, without a soft tissue component. 2. Any bleeding disorders or anticoagulation that cannot be corrected and that would render the risk of biopsy unacceptable. 3. 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. 4. Eastern Cooperative Oncology Group performance status of 3 and higher. 5. Known chronic infectious disease (Hepatitis B and C, HIV) that may impact patient safety. 6. Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
Contact & Investigator
Stephen-John Sammut
PRINCIPAL INVESTIGATOR
Royal Marsden NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT07084571 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07084571 currently recruiting?
Yes, NCT07084571 is actively recruiting participants. Contact the research team at FORTITUDE@rmh.nhs.uk for enrollment information.
Where is the NCT07084571 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07084571 clinical trial?
NCT07084571 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Stephen-John Sammut at Royal Marsden NHS Foundation Trust. The trial plans to enroll 200 participants.
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