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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (2 UK sites)
Guy's and St. Thomas NHS Foundation Trust
London SE1 9RT, United Kingdom
King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
How to Get in Touch
Anthony Kong
Sponsor contactCONTACT
Christiana Cattaneo
Sponsor contactCONTACT
