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

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Jul 17, 2025

Keywords

ClinConnect Summary

This study, called FORTITUDE, is looking at how breast cancer changes over time, especially in patients whose cancer has spread to other parts of the body. The researchers want to see if it’s possible to take small tissue samples (biopsies) from different tumor sites at several points during treatment. By examining these samples and blood, they hope to better understand how the cancer evolves and sometimes becomes resistant to treatment. This knowledge could help doctors choose better treatments in the future and develop new ways to monitor how well treatments are working.

People who have advanced or metastatic breast cancer, meaning the cancer has spread beyond the breast, may be eligible to join if they are 18 or older and able to give consent. However, patients whose cancer has only spread to bones, or those with certain health risks that make biopsy unsafe, would not qualify. If you participate, you can expect to have needle biopsies from multiple tumor sites taken at different times during your treatment, along with blood samples. These procedures will help researchers study the cancer’s changes but will be done carefully to minimize risks. This study is not yet recruiting participants but aims to improve how breast cancer is understood and treated in the future.

Gender

ALL

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.