RecruitingNot Applicable

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

United Kingdom200 participantsStarted 2026-02-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients having two or more tumour sites sampled in one procedural sitting when technically feasible

Timeframe: Through study completion, 15 years

Proportion of patients having longitudinal sampling in those progressing on treatment

Timeframe: Through study completion, 15 years

Proportion of patients willing to undergo multisite sampling again in the future if clinically required

Timeframe: Through study completion, 15 years

Trial details

NCT IDNCT07084571

SponsorRoyal Marsden NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2040-04

Contact for this trial

Sophie Cooke

02034373610 FORTITUDE@rmh.nhs.uk

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.
. 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.

What they're measuring

Proportion of patients having two or more tumour sites sampled in one procedural sitting when technically feasible

Timeframe: Through study completion, 15 years

Proportion of patients having longitudinal sampling in those progressing on treatment

Timeframe: Through study completion, 15 years

Proportion of patients willing to undergo multisite sampling again in the future if clinically required

Timeframe: Through study completion, 15 years