Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Organoids to predict treatment outcomes for breast cancer metastases

Official title: Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Breast Cancer Patients With Brain and/or Extra-cranial Metastases

Run by King's College London · NCT06468124 · Data updated 2026-11-12

This project will try to grow mini-tumors (organoids) from people with breast cancer metastases to see if lab responses predict each patient’s response to radiation and chemotherapy.

More Breast Neoplasms trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorKing's College London
Academic / other
Drugs / interventionsimmunotherapy
Locations2 sites (London and 1 other locations)
StatusRecruiting
StartedMay 27, 2025
Main results expectedJune 30, 2026
Study endsJune 30, 2026
Registry record updatedDecember 22, 2025
Trial IDNCT06468124 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (age >18) with breast cancer who are undergoing surgical resection or biopsy of brain or extra‑cranial metastases and who can give informed consent are ideal candidates.

Probably not a fit

Patients without resectable or biopsiable metastatic tissue, those unable to consent, or those whose tumor samples fail to grow organoids are unlikely to benefit directly.

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

What this trial studies

The project will collect tissue from surgically resected or biopsied brain and extra‑cranial breast cancer metastases and generate patient‑derived organoids (PDOs). When organoids contain sufficient cells, investigators will expose them to increasing doses of radiotherapy and to the systemic treatments the patients received or will receive to measure dose‑response and IC50. Researchers will correlate PDO radio‑ and chemo‑sensitivity with patients’ clinical treatment responses and survival while patients continue standard clinical care. The pilot phase aims to enroll about 20 patients at two London hospital sites.

Why it matters

Potential benefit: If successful, PDO testing could help personalize therapy by identifying which radiation or systemic treatments are most likely to work for an individual patient's metastases.

How similar studies have gone: Organoid-based drug testing has shown promising concordance with patient response in several cancer types and small breast cancer series, but its use to predict outcomes for metastatic breast cancer remains experimental.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Breast cancer patients with brain metastases who are suitable for surgical resection or Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
* Age \> 18 years old

Exclusion Criteria:

* Patients unable to give informed consent e.g., mental disability or vulnerable adults

Where it's running

  • Guy's and St. Thomas NHS Foundation Trust
    London, United Kingdom
    Recruiting
  • King's College Hospital NHS Foundation Trust
    London, United Kingdom
    Recruiting

Study contacts

  • Principal investigator: Anthony Kong — Clinical reader and honorary NHS consultant in clinical oncology
  • Study coordinator: Anthony Kong
  • Email: Anthony.kong@kcl.ac.uk
  • Phone: 0207 848 8302

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.