Not Yet RecruitingPhase 3

Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

938 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range60 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Ipsilateral breast cancer recurrence

Timeframe: Until 5 years after the intervention

Trial details

NCT IDNCT07483996

SponsorFranciscus Gasthuis & Vlietland (Hospital)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-12-31

Contact for this trial

Linda Riks, MD

010 - 893 6010 l.riks@franciscus.nl

View on ClinicalTrials.gov More Early-Stage Breast Cancer trials