Developing Breast (Cancer) Organoids

Currently, only a few validated biomarkers and models exist guiding or predicting treatment response for specific patient groups. Therefore, a patient-tailored clinical model needs to be developed to address tumour heterogeneity and thereby guide treatment selection on an individualized level. Organoids are patient-derived aggregates that grow in 3D and maintain self- renewal pluripotency and lineage-specific differentiation. Therefore, in contrast with conventional cell lines, they are thought to sustain patient heterogeneity and characteristics and are consequently already in use for drug response screening.

This now offers the opportunity to investigate if the primary patient breast cancer organoid platform reflects disease progression, treatment response and relapse in patients with different clinical breast cancer subtypes.

Goal: To develop a living biobank from prospective patient-derived breast cancer tissue. The questions we will address are:

1. Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour?
2. Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions?
3. Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients?
4. Can BC organoids be used to discover mechanisms of treatment resistance and relapse?

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Not an extra intervention, tissue taken in routine practice will be used.

Detailed Description

The investigators will select patients with a diagnosis of breast cancer who undergo breast surgery. Patients will be asked informed consent for the use of a small (0,2-1 cm3) sample of the excised breast tumour and the collection of a blood sample (6ml)for whole-exome sequencing (WES) to compare the genetic profile of the patients with the organoids and the patient biopsy. The patients will not undergo any additional treatment or procedure in addition to the planned routine procedure for the surgical resection of their primary breast tumour.

Patient will undergo standard diagnostic procedures and treatment according to the Dutch breast cancer surgery guidelines. After surgery, the pathologist will provide -after pathological diagnosis- rest (tumour) tissue from the resection to the lab. This material will then be used to develop breast cancer organoids. As part of the routine surgical procedure, 6 ml of blood will be collected. Participation in this study does not lead to additional actions other than reading the patient information and signing the informed consent. Therefore, participation does not change the patient's treatment or outcome.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Chantal Overhof; Phone Number: +31 88 44 55 683; Email: chantal.overhof@maastro.nl
• Study Contact Backup: Name: Ann Claessens; Phone Number: +31 88 44 55 600; Email: ann.claessens@maastro.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202 AZ
    • Recruiting
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All breast cancer patients that meet the criteria mentioned above.

Description

Inclusion Criteria:

• Female,
• >18 years,
• Family Anamneses
• Breast cancer (proven by histopathology), Included subtypes; (ER-,PR- HER2-); (ER+, PR+, HER2-); (ER+, PR+ HER2+).
• Primary surgery (lumpectomy or mastectomy)

Exclusion Criteria:

- Physically or mentally incapable or incompetent to sign informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; The is only 1 arm: all breast cancer patients undergoing surgery.	Other: Not an extra intervention, tissue taken in routine practice will be used.; No extra intervention: using tumour tissue taken during surgery in standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Living biobank	The development of a patient derived breast cancer living biobank using 3D organoid technology reflecting the most prominent clinical subtypes.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organoids.	Cultivate breast cancer organoids that can be used to predict the treatment response to existing and novel combination treatments.	12 months

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Collaborators: Maastricht University Medical Center; Maastricht University
• Investigators: Principal Investigator: Marc Vooijs, PhD, Maastricht University; Principal Investigator: Marjolein Smidt, MD, PhD, Maastricht University Medical Center; Principal Investigator: Loes Kooreman, MD, Maastricht University Hospital (MUMC+); Principal Investigator: Maaike De Boer, MD, PhD, Maastricht University Hospital (MUMC+)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Organoids Breast

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No