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Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases

Sponsor: King's College London

NCT ID: NCT06468124

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 13 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by King's College London, is looking at breast cancer that has spread (metastases). Researchers want to test whether lab-grown cell models called organoids can help predict how treatment will work. The purpose and detailed design are not fully described in the registry data — ask the trial team for more information.

Who can take part

  • Adults over 18 with breast cancer that has spread to the brain, who are able to have surgery to remove it
  • Adults over 18 with breast cancer that has spread outside the brain (for example, to other parts of the body), who are having surgery or a small sample of tissue taken (a biopsy)

Who may not be able to

  • People who cannot give informed consent, for example due to a mental disability or because they are considered a vulnerable adult

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
20
Started
2025-05-27
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for breast neoplasms
  • • Clinical study - 20 participants
  • • The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast neoplasms

Where?

  • • London - Guy's and St. Thomas NHS Foundation Trust
  • • London - King's College Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.

More detail

The SOTO-BC trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care. Patient cohorts: 1. Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy) 2. Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy Primary objective: To assess the percentage of successful generated organoids from resected brain or resected/biopsied extra-cranial metastases of breast cancer patients Secondary objectives: 1. To assess the sensitivity of radiotherapy in PDOs 2. To assess the sensitivity of the same systemic treatments that the patients previously had and will have in PDOs 3. To correlate the treatment sensitivities of PDOs above with the treatment outcome of patients 4. To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment Study Procedures: Breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resected/biopsied samples to be used to generate PDOs. The investigators aim to recruit 20 patients in the pilot phase of the study. When the PDOs contain sufficient cells, these cells will be treated with increasing doses of radiotherapy and/or relevant systemic treatments in order to determine the IC50 and to obtain dose-response curves of these PDOs to the treatments. The investigators will treat the PDOs with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy and/or systemic treatments including immunotherapy (co-cultured with immune cells). The response of these PDOs will be compared to the treatment outcome and survivals in these patients.

Breast Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Breast cancer patients with brain metastases who are suitable for surgical resection or Breast cancer patients with...
  • ✓Age \> 18 years old

Who cannot take part

  • ✗Patients unable to give agreement to take part e.g., mental disability or vulnerable adults
See the full 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 Is This Study? (2 UK sites)

Guy's and St. Thomas NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)

King's College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Anthony Kong

Sponsor contact

CONTACT

0207 848 8302 Anthony.kong@kcl.ac.uk

Christiana Cattaneo

Sponsor contact

CONTACT

0207 848 8302 christiana.1.cattaneo@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-12