Breast Cancer Trial, Recruiting NCT06362616 Sponsor: The Netherlands Cancer Institute Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT06362616
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:

  • You are a woman aged 51 or older
  • You have breast cancer that has come back in the same breast, or a new breast cancer in the same breast you were previously treated
  • Your cancer has been confirmed by biopsy as either an invasive breast cancer (with or without a non-invasive component) or a non-invasive type called DCIS that shows up as calcium deposits on imaging
  • Your cancer has been confirmed by biopsy to be estrogen receptor (ER) positive (meaning it is fuelled by the hormone oestrogen)
  • Your cancer has been confirmed to be HER2 negative (a specific protein is not present in high amounts)
  • If your cancer is invasive, the tumour is no larger than 3 cm; if it is DCIS only, the affected area is no larger than 2.5 cm
  • Your tumour is classed as grade 1 or grade 2 (low to moderate growth rate), based on biopsy results
  • There is no sign that the cancer has spread to your lymph nodes or other parts of the body
  • The cancer appears in just one area on mammogram and MRI scans (small closely neighbouring spots may still be acceptable — confirm with trial site)
  • It has been more than 12 months since you completed treatment for your original breast cancer
  • You previously had radiotherapy to the same breast
  • Surgeons have confirmed it is possible to remove the cancer again while keeping the breast (repeat breast-conserving surgery)
  • You are generally well enough to take part, based on a standard health assessment scale (WHO performance score of 2 or below)
  • You are able to give written consent to take part and are legally able to make your own decisions

Who may not be able to join:

  • You experienced severe side effects (grade 3 or higher) from radiotherapy to the breast during your previous treatment
  • You previously had a focused "boost" of radiotherapy aimed directly at the tumour area — unless the current tumour is in a different area of the breast that did not receive that boost
  • Your cancer has spread to other parts of the body, or you also have a new cancer in the opposite breast
  • Your biopsy has shown a specific type of breast cancer called invasive lobular carcinoma (ILC) or pleomorphic lobular carcinoma in situ (LCIS)
  • Your cancer is oestrogen receptor (ER) negative
  • Your biopsy shows that cancer cells have spread into nearby blood or lymph vessels (lymphovascular invasion)
  • You have already received, or are planned to receive, chemotherapy or other systemic drug treatment for this current tumour before surgery (a short course of hormone therapy of up to 2 months before surgery is an exception)
  • You are planned to have a type of surgery that involves moving large amounts of tissue from another area to reshape the breast
  • You are already taking part in another clinical trial that involves treatment to the breast or surrounding area
  • Doctors believe it will not be possible to give radiotherapy at safe levels that protect your lungs and heart (confirm with trial site)
  • You have a confirmed BRCA gene mutation

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 2 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

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
The Netherlands Cancer Institute
Registry
ClinicalTrials.gov
Start date
12 April 2024
Est. completion
11 October 2026

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Acute post-treatment toxicity

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: 2 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