Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases
NCT ID: NCT06468124
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-05-27
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
No interventions assigned to this group
Breast cancer patients with extra-cranial metastases
Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years old
Exclusion Criteria
18 Years
ALL
No
Sponsors
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King's College London
OTHER
Responsible Party
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Principal Investigators
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Anthony Kong
Role: PRINCIPAL_INVESTIGATOR
Clinical reader and honorary NHS consultant in clinical oncology
Locations
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Guy's and St. Thomas NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Anthony Kong
Role: primary
Taylor McKenzie
Role: backup
Keyoumars Ashkan
Role: primary
Taylor McKenzie
Role: backup
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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315793
Identifier Type: -
Identifier Source: org_study_id