NCT05317221

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
24mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Sep 2022May 2028

First Submitted

Initial submission to the registry

March 16, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

5.6 years

First QC Date

March 16, 2022

Last Update Submit

May 6, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Organoids.

    12 months

Study Arms (1)

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.

Interventions

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.

All patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All breast cancer patients that meet the criteria mentioned above.

You may qualify if:

  • 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)

You may not qualify if:

  • \- Physically or mentally incapable or incompetent to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Extra tube of blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • 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+)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Overhof

CONTACT

+31 88 44 55 683chantal.overhof@maastro.nl

Ann Claessens

CONTACT

+31 88 44 55 600ann.claessens@maastro.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 7, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

May 7, 2025

Record last verified: 2025-04

Locations

NL(1)