Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases (PDO)

December 15, 2025 updated by: King's College London

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients with resectable brain or extra-cranial metastases and undergoing postoperative radiotherapy or palliative radiotherapy to extracranial metastases if necessary +/- other systemic treatments after resection. Patients who will undergo a biopsy of the extra-cranial metastases may be recruited and asked to consent for an additional research biopsy at the same time as standard of care biopsy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast cancer patients with brain metastases
Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy)
Breast cancer patients with extra-cranial metastases
Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient derived organoids
Time Frame: 10 months
To generate PDOs from brain or extra-cranial metastases of breast cancer patients.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to radiotherapy
Time Frame: 6 months
To determine the dose response curves of radiotherapy
6 months
Response to therapy
Time Frame: 5 months
To determine the IC50 doses of the previous and same systemic treatments that patients had or will have in PDOs
5 months
recurrence and survival rates
Time Frame: 4 months
To correlate the IC50 doses and dose response curves above with the recurrence rates and progression-free survival of patients
4 months
Response rate of patients undergoing systemic treatment
Time Frame: 3 months
To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Anthony Kong, Clinical reader and honorary NHS consultant in clinical oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 315793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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