Organoids to predict treatment outcomes for breast cancer metastases
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
King's College London · NCT06468124
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London (other) |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT06468124 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasms