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

NCT07084571 | Recruiting

• 1 other identifier: CCR5876
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer

Keywords

Interventional Radiology

Outcome Measures

Primary Outcomes (3)

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

  Through study completion, 15 years

• Proportion of patients having longitudinal sampling in those progressing on treatment

  Through study completion, 15 years

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

  Through study completion, 15 years

Secondary Outcomes (9)

• Quantification of procedural complication rates

  Through study completion, 15 years

• Quantification of duration of biopsy procedures

  Through study completion, 15 years

• Accuracy of tumour biopsies

  Through study completion, 15 years

• Quantification of proportion of samples adequate for molecular profiling

  Through study completion, 15 years

• Number of clinically relevant molecular alterations detected using multisite, multiregion, and serial sampling

  Through study completion, 15 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Metastatic breast cancer or locally advanced, inoperable breast cancer patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Eastern Cooperative Oncology Group performance status of 3 and higher.
• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples Blood samples Biological fluid samples

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephen-John Sammut

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Cooke

CONTACT

02034373610; FORTITUDE@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 24, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): April 1, 2040
• Study Completion (Estimated): April 1, 2040
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

GB (1)