Study for people with Breast Cancer

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor Amsterdam UMC, location VUmc
Registry number NCT05350722
Started 24 August 2022 Today 16 October 2026 Estimated completion 1 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
GenesisCare Sydney Australia Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 40 Years and over
Sex Female participants only
Healthy volunteers Not accepted
Enrolment target 100

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* WHO performance scale ≤2.

* Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.

* Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.

* Tumor size as assessed on MRI.

* On tumor biopsy:

* Bloom-Richardson grade 1 or 2.

* Non-lobular invasive histological type carcinoma.

* LCIS or (non-extensive) DCIS is accepted.

* ER positive tumor receptor.

* HER2 negative tumor.

* Tumor-negative sentinel node (excluding isolated tumor cells).

* Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

* Legal incapacity.

* BRCA1, BRCA2 or CHEK2 gene mutation.

* Distant metastasis.

* Previous history of breast cancer or DCIS.

* Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.

* For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.

* Collagen synthesis disease.

* Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).

* Invasive lobular carcinoma.

* MRI absolute contraindications as defined by the Department of Radiology.

* Nodal involvement with cytological or histological confirmation.

* Indication for treatment with (neo-)adjuvant chemotherapy.

* Non-feasible dosimetric RT plan.

Dates on the record

Started 24 August 2022
Estimated completion 1 December 2027
Registry last updated 16 July 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 16 July 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.