Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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.
Primary outcome measures
- Patient derived organoids [Time frame: 10 months]
Secondary outcome measures (4)
- Response to radiotherapy [Time frame: 6 months]
- Response to therapy [Time frame: 5 months]
- recurrence and survival rates [Time frame: 4 months]
- Response rate of patients undergoing systemic treatment [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 2 centers
- Guy's and St. Thomas NHS Foundation Trust — London
- King's College Hospital NHS Foundation Trust — London
Identifiers
NCT: NCT06468124 · 315793