Serial multisite image-guided biopsies to track breast cancer evolution

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: FORTITUDE@rmh.nhs.uk
• Phone: 02034373610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adaptive biomarker-driven therapies for metastatic breast cancer

  This trial tests whether matching targeted drug combinations to tumor biomarkers helps people with ER+/HER2- or triple-negative metastatic breast cancer who are starting second-line treatment.

  Recruiting at 4 sites Phase 2 UNC Lineberger Comprehensive Cancer Center · New Haven, Connecticut and 5 other locations · NCT07340541

• Combining pembrolizumab with cryoablation for metastatic breast cancer

  This study is testing if combining a drug called pembrolizumab with a freezing treatment can help people with advanced triple negative breast cancer feel better compared to just using the drug alone.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06246968

• Combining radiation therapy with pembrolizumab and olaparib for certain breast cancers

  This study tests if adding pembrolizumab, with or without olaparib, to standard radiation therapy can help women with advanced breast cancer feel better compared to just radiation therapy alone.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT04683679

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.