Breast CancerNCT05317221
Developing Breast (Cancer) Organoids
An observational study of Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Not an extra intervention, tissue taken in routine practice will be used.
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All breast cancer patients that meet the criteria mentioned above.
Who may be able to join
- 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)
Who cannot join
- Physically or mentally incapable or incompetent to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, 6202 AZ
About this study
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.
Read more
Goal: To develop a living biobank from prospective patient-derived breast cancer tissue. The questions we will address are:
- Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour?
- Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions?
- Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients?
- Can BC organoids be used to discover mechanisms of treatment resistance and relapse?
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Not an extra intervention, tissue taken in routine practice will be used.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | The is only 1 arm: all breast cancer patients undergoing surgery. Receives: Other: Not an extra intervention, tissue taken in routine practice will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Living biobank
The development of a patient derived breast cancer living biobank using 3D organoid technology reflecting the most prominent clinical subtypes.
Measured: 12 months
Secondary outcomes (1)
Organoids.
Cultivate breast cancer organoids that can be used to predict the treatment response to existing and novel combination treatments.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Marc Vooijs, PhD, Principal investigator, Maastricht UniversityMarjolein Smidt, MD, PhD, Principal investigator, Maastricht University Medical CenterLoes Kooreman, MD, Principal investigator, Maastricht University Hospital (MUMC+)Maaike De Boer, MD, PhD, Principal investigator, Maastricht University Hospital (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317221
- Sponsor's protocol ID
- Organoids Breast
- Status last verified
- May 2026
- First submitted
- 16 Mar 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Breast (Cancer) Organoids
- ClinicalTrials.gov ID
- NCT05317221
- Acronym / sponsor ID
- Organoids Breast
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Maastricht University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour?
- Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions?
- Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients?
- Can BC organoids be used to discover mechanisms of treatment resistance and relapse?
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: Not an extra intervention, tissue taken in routine practice will be used.The is only 1 arm: all breast cancer patients undergoing surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All breast cancer patients that meet the criteria mentioned above.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Physically or mentally incapable or incompetent to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | All patients |
Primary outcome
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.
1 secondary outcome
Organoids.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Vooijs, PhD principal investigator
Maastricht University
Marjolein Smidt, MD, PhD principal investigator
Maastricht University Medical Center
Loes Kooreman, MD principal investigator
Maastricht University Hospital (MUMC+)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal Overhof (+31 88 44 55 683, chantal.overhof@maastro.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Living biobank (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.