Breast Cancer Trial, Recruiting NCT06476119 Sponsor: The Netherlands Cancer Institute Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT06476119
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 of any gender, aged 18 or older
  • People who are able to give written consent to take part in the trial
  • People diagnosed with triple-negative breast cancer (TNBC), meaning the cancer cells tested negative for hormone receptors (ER/PR at 0–9%) and negative for HER2, confirmed on both the initial biopsy and the tissue removed during surgery
  • People with stage I TNBC where the invasive tumour measured no more than 2 cm, and where the cancer had not spread to any lymph nodes (certain very small or borderline findings may not qualify — confirm with trial site)
  • People whose imaging scans (including a specific full-body scan called an 18F-FDG-PET/CT, or a CT scan if that is not available) showed no signs of cancer spread to lymph nodes or other parts of the body
  • People whose cancer tissue showed a high level of immune cells (called tumour-infiltrating lymphocytes, or TILs) in the surgical sample — at least 50% for people aged 40 or older at diagnosis, and at least 75% for people under 40 at diagnosis, confirmed by both local and central review
  • People who have already had surgery to remove the breast cancer (either breast-conserving surgery or mastectomy), including a procedure to check the lymph nodes
  • People who show no signs of the cancer coming back between surgery and expressing their preference about taking part
  • People for whom radiotherapy is considered appropriate, if it has been recommended

Who may not be able to join:

  • People with a previous history of invasive or non-invasive breast cancer, or who are currently being treated for breast cancer
  • People whose breast cancer is found in multiple areas of one or both breasts at the time of screening
  • People who received systemic treatment (such as chemotherapy) before their breast surgery
  • People whose biopsy or surgical tissue showed signs that cancer cells had spread into blood vessels or lymph vessels (lymphovascular invasion)
  • People who have had another invasive cancer within the past 5 years — although certain exceptions may apply, such as some types of skin cancer, localised cervical cancer, or low-grade localised prostate cancer (confirm with trial site)
  • People with a serious illness or medical condition that is not well controlled
  • People whose personal, psychological, family, or geographic circumstances may make it difficult to follow the trial's schedule and requirements (the trial site will discuss this with the person before enrolment)

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 27 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

Principal Investigator: Marleen Kok, MD, Antoni van Leeuwenhoek

Phone: +31205129111

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

GP referral letter

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

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
The Netherlands Cancer Institute
Registry
ClinicalTrials.gov
Start date
15 April 2025
Est. completion
15 September 2032

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population

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: 27 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