Breast Cancer Trial, Not Yet Recruiting NCT07635654 Sponsor: KU Leuven Condition: Breast Cancer
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Breast Cancer Trial, Not Yet Recruiting

NCT07635654
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • The person joining (or their legal representative) must have given voluntary written agreement to take part before any screening tests are done.
  • The person must be at least 18 years old at the time of signing the consent form.
  • The person must have an ECOG performance score of 0, 1, or 2 — this is a measure of how much the illness affects daily activity (confirm with trial site).
  • The person must have stage IV invasive lobular breast cancer (ILC), either diagnosed at that stage from the start, or returning after earlier treatment aimed at a cure; the cancer type must be confirmed by tissue testing from either the original tumour or a spread (metastatic) site. People whose breast cancer has a mixed tumour type (part ILC and part another type, within the same tumour) may also be eligible and would be included in a separate exploratory group.
  • The cancer must be hormone receptor positive (HR+) and HER2 negative, confirmed either by a new biopsy or by previously stored tissue samples.
  • People with cancer present in multiple spots or in both breasts may be eligible, as long as all assessed areas show the same HR+/HER2- ILC type.
  • The person must be starting their first treatment for metastatic ILC (i.e., treatment for cancer that has spread).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People for whom a whole-body MRI scan (WB-DWI/MRI) is medically not recommended or not safe.
  • People who experience severe claustrophobia (extreme fear of enclosed spaces, such as inside an MRI machine).
  • People for whom the dye (contrast) used in CT or PET/CT scans is medically not recommended or not safe (for example, due to an allergy or severe kidney problems), if a scan without contrast cannot be performed instead.
  • People whose cancer has spread to only a small number of spots (called oligometastatic disease) and who are expected to have localised treatment targeting those specific areas.
  • People who have had another type of cancer within the last 5 years.
  • People who are female and are currently pregnant, breastfeeding, planning to become pregnant, or are of childbearing potential and are not using a highly effective form of contraception.
  • Adults who are under a legal protection order or who are not able to give their own consent.

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 10 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.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
KU Leuven
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
30 June 2030

Primary endpoints

Percentage of cases where WB-DWI/MRI contributed solely to the decision of progression and/or treatment change assessed by questionnaires filled out by the treating oncologist at the time of progression

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: 10 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