Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases

Breast Neoplasms Clinical Trial

— PDO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468124
• Other study ID #: 315793
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: King's College London
• Contact: Anthony Kong
• Phone: 0207 848 8302
• Email: Anthony.kong[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient derived organoids	To generate PDOs from brain or extra-cranial metastases of breast cancer patients.	10 months
Secondary	Response to radiotherapy	To determine the dose response curves of radiotherapy	6 months
Secondary	Response to therapy	To determine the IC50 doses of the previous and same systemic treatments that patients had or will have in PDOs	5 months
Secondary	recurrence and survival rates	To correlate the IC50 doses and dose response curves above with the recurrence rates and progression-free survival of patients	4 months
Secondary	Response rate of patients undergoing systemic treatment	To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment	3 months