Phase 3 Breast Cancer Trial, Not Yet Recruiting
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 participant must be a woman.
- The participant must be older than 60 years of age.
- The participant must be postmenopausal, meaning no menstrual period for at least 12 months, or — if an intra-uterine device (IUD) is in place — hormone test results showing levels consistent with menopause (confirm with trial site).
- The participant must have a confirmed diagnosis of a specific type of breast cancer called primary invasive ER-positive/HER2-negative breast cancer, verified by laboratory testing of tissue.
- The breast cancer must be classified as Bloom Richardson grade 1 or 2, meaning it is considered low or intermediate in how abnormal the cancer cells appear under a microscope.
- The breast cancer must be in one breast only and in one single location.
- The tumor must be no larger than 2cm, with no spread to nearby lymph nodes or distant parts of the body, based on ultrasound and/or MRI imaging.
- The tumor must be clearly visible with well-defined edges on ultrasound, both at the time of diagnosis and during any procedure.
- The participant must have a sufficient understanding of the Dutch language to complete study questionnaires.
- The participant must be able to give written informed consent.
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 with a previous history of invasive breast cancer.
- People who have had breast augmentation (implants or other breast enlargement procedures).
- People who carry a BRCA-1 or BRCA-2 gene mutation.
- People whose breast cancer is of the lobular carcinoma type.
- People whose breast cancer is classified as triple negative breast cancer.
- People whose cancer is present in multiple locations within the breast (multifocality).
- People whose tumor overexpresses the HER2-neu protein.
- People whose biopsy or surgical tissue results show lymph vascular invasion (cancer cells found inside blood or lymph vessels).
- People for whom doctors have determined that pre-surgery drug treatment (neoadjuvant systemic therapy) is needed.
- People whose tumor has a large intraductal component (more than 25% of the tumor's diameter on MRI), or where the total area of the tumor exceeds 2cm (confirm with trial site).
- People with a known allergy to local anaesthetics.
- People who have electrical devices or implants in their body that are not safe for use with MRI.
- People currently experiencing a severe breast infection.
- People with a blood clotting disorder that cannot be corrected.
- People who are medically unstable in terms of heart and circulation function.
- People who are medically unstable in terms of breathing function.
- People who do not wish to receive radiotherapy after their main treatment.
- People for whom a more complex surgical technique involving tissue rearrangement or volume replacement (such as a LICAP procedure) has been recommended.
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.
Contact this trial
Principal Investigator: T.M.A.L. GE Klem, MD, PhD, Franciscus Gasthuis & Vlietland
Phone: 010 - 893 6010
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
Primary endpoints
Ipsilateral breast cancer recurrence
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.