Serial multisite image-guided biopsies to track breast cancer evolution

Feasibility of Serial Multisite Image-Guided Biopsy To Study Breast Cancer Evolution

The team will try taking repeated image-guided biopsies and blood samples from adults with metastatic or advanced breast cancer to see how their tumors change during treatment.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal Marsden NHS Foundation Trust (other)
• Locations: 1 site (London)
• Trial ID: NCT07084571 on ClinicalTrials.gov

What this trial studies

This observational translational project collects serial needle biopsies from multiple tumor sites and matched blood samples from adults with metastatic or locally advanced breast cancer. Participants undergo image-guided percutaneous biopsies at baseline and at defined time points during therapy or disease progression, targeting accessible soft-tissue metastases across different organs. Samples are analyzed with molecular and genetic techniques, including next-generation sequencing, to map tumor heterogeneity and identify changes associated with treatment resistance. The primary aim is to test feasibility and patient acceptability of multisite serial sampling and to build a tissue bank to support research into metastatic breast cancer evolution.

Who should consider this trial

Good fit: Adults (aged 18 and over) with histologically confirmed locally advanced, inoperable or metastatic breast cancer who can give informed consent and have at least one accessible soft-tissue metastasis suitable for image-guided biopsy are ideal candidates.

Not a fit: Patients with bone-only metastases, uncorrectable bleeding disorders or anticoagulation, poor performance status (ECOG ≥3), or certain chronic infectious diseases are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could help clinicians detect emerging resistance sooner and guide more personalized treatment choices.

How similar studies have performed: Prior sequencing studies have shown that metastatic tumors are heterogeneous and evolve under treatment, and while serial or repeat biopsies have yielded important biological insights, the feasibility of routine multisite serial sampling across timepoints is still not widely established.

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.

Where this trial is running

London

• Royal Marsden NHS Foundation Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Stephen-John Sammut — Royal Marsden NHS Foundation Trust
• Study coordinator: Sophie Cooke

Conditions: Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, Interventional Radiology