Breast Cancer Trial, Recruiting NCT04531696 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT04531696
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older.
  • People who are willing and able to sign a consent form for the trial.
  • People who have metastatic breast cancer, or a hereditary cancer syndrome with a moderate to high lifetime risk of breast cancer, and who are either treated or followed at UZ Leuven, or treated at another hospital and referred to UZ Leuven specifically for this trial.

For specific parts of the trial, additional criteria apply:

  • ILC substudy: People who have a confirmed history of a specific type of breast cancer called invasive lobular carcinoma (ILC), confirmed by tissue testing.
  • IBC substudy: People who have a history of inflammatory breast cancer (IBC), meeting specific clinical criteria including rapid onset of breast redness, swelling, skin changes and/or warmth, lasting no more than 6 months, with redness covering at least one-third of the breast, and confirmed by tissue testing (confirm with trial site).
  • Hereditary cancer syndrome substudy: People who have a confirmed inherited gene change linked to a moderate to high lifetime risk of breast cancer (for example, changes in genes such as BRCA1, BRCA2, CHEK2, TP53, or PALB2), and who have at least one active cancer lesion of any type at the time of joining.

Who may not be able to join:

  • People who have a transmissible (infectious) disease that could pose a health risk to researchers or those handling patient samples. This includes but is not limited to: HIV, active hepatitis C, encephalitis of unknown cause, Creutzfeldt-Jakob disease, rabies, active malaria, active tuberculosis, or active COVID-19 (SARS-CoV-2).
  • People whose circumstances could make it difficult to carry out the study procedures within the required timeframes — for example, living far from UZ Leuven, living outside of Belgium, or situations where it would not be possible to notify the medical team quickly enough in the event of death.
  • ILC and IBC substudies only: People who have been diagnosed with any cancer other than breast cancer in the 5 years before joining. Exceptions are made for certain skin cancers (basal cell carcinoma or squamous cell carcinoma of the skin) and early-stage cervical cancer confined to the surface (in situ cervical carcinoma).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 003216336539

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
30 November 2020
Est. completion
1 September 2035

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Percentage of patients consenting to participate in the pilot phase; Median time elapsed between moment of death and start of the autopsy; Median time elapsed between collection of first and last sample; Percentage of metastatic organs sampled; Percentage of samples with sufficient quality of DNA extracted; Percentage of samples with sufficient quality of RNA extracted

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov