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NCT Number: NCT05317221

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?

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not an extra intervention, tissue taken in routine practice will be used.

Other

No extra intervention: using tumour tissue taken during surgery in standard of care.

Primary outcomes

  1. Living biobank

    Time frame: 12 months

    The development of a patient derived breast cancer living biobank using 3D organoid technology reflecting the most prominent clinical subtypes.

Secondary outcomes

  1. Organoids.

    Time frame: 12 months

    Cultivate breast cancer organoids that can be used to predict the treatment response to existing and novel combination treatments.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Claessens

CONTACT

[email protected]

+31 88 44 55 600

Chantal Overhof

CONTACT

[email protected]

+31 88 44 55 683

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Maastricht University
  • Maastricht University Medical Center

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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