Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases

NCT06468124 | Recruiting

• 1 other identifier: 315793
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Patient derived organoids

  To generate PDOs from brain or extra-cranial metastases of breast cancer patients.

  10 months

Secondary Outcomes (4)

• Response to radiotherapy

  6 months

• Response to therapy

  5 months

• recurrence and survival rates

  4 months

• Response rate of patients undergoing systemic treatment

  3 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients unable to give informed consent e.g., mental disability or vulnerable adults

Sponsors & Collaborators

• King's College London: lead

Study Sites (2)

Guy's and St. Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumour and normal tissues, blood, saliva, oral swabs, urine and stool

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anthony Kong

  Clinical reader and honorary NHS consultant in clinical oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Kong

CONTACT

0207 848 8302; Anthony.kong@kcl.ac.uk

Christiana Cattaneo

CONTACT

0207 848 8302; christiana.1.cattaneo@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 21, 2024
• Study Start: May 27, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

GB (2)