Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

Starting soon · Phase 3

Conditions studied: Early-Stage Breast Cancer

In brief

The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.

Key facts

Study ID

NCT07483996

Run by

Franciscus Gasthuis & Vlietland (Hospital)

People needed

938

Starts

2026-04-01

Expected to finish

2038-12-31

Last updated by the study team

2026-03-19

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women
• Age > 60 years
• Postmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) > 20 IE/l and estradiol < 100 pmol/l)
• Histopathological confirmed primary invasive ER+/HER2- type breast cancer
• Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade)
• Unilateral and unifocal breast cancer
• A clinical T1N0M0 tumor (≤ 2cm and N0 on US and/or MRI), without distant metastases. The largest diameter measured will be used to determine eligibility.
• Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure.
• Sufficient knowledge of the Dutch language to complete the questionnaires
• To be able to give written informed consent

You may not qualify if…

• History of invasive breast cancer
• Breast augmentation
• BRCA-1 or 2 gene mutation carrier
• Lobular carcinoma
• Triple negative breast cancer
• Multifocality
• HER2-neu overexpressing tumors
• Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy
• Indication for neoadjuvant systemic therapy
• Intraductal component > 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm.
• Allergic to local anesthetics
• Electrical devices and/or implants that are not compatible with MRI
• Current severe breast infection
• Uncorrectable coagulopathy
• Hemodynamic instability
• Respiratory instability
• Refraining from adjuvant radiotherapy
• Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)

Full record on ClinicalTrials.gov

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