Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

NCT07483996 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: NL-010714
• Study Type: interventional
• Target: 938
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early-Stage Breast Cancer

Keywords

Breast Cancer; Early-Stage Breast Cancer; Borstkanker; Vroegstadium Borstkanker

Outcome Measures

Primary Outcomes (1)

• Ipsilateral breast cancer recurrence

  Proportion of ipsilateral breast cancer recurrences (IBTR) after 5 years in both study arms.

  Until 5 years after the intervention

Secondary Outcomes (14)

• Complication Rate

  Within 30 days after the intervention

• Regional breast cancer recurrences

  Until 5 years after the intervention

• Disease Free Survival

  until 15 years after the intervention

• Overall Survival

  through study completion, an average of 15 years

• Cosmetic Outcomes

  at baseline, 6 months and 1 year after the intervention

Other Outcomes (1)

• Any other parameters

  until the end of the study, which is an average of 5 years

Study Arms (2)

Patients will be treated with ultrasound-guided percutaneous cryoablation

ACTIVE COMPARATOR

Ultrasound-guided percutaneous cryoablation

Procedure: Percutaneous cryoablation

Breast-conserving surgery

OTHER

Patients will be treated with breast-conserving surgery.

Procedure: Breast-conserving surgery

Interventions

Percutaneous cryoablation PROCEDURE

In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.

Also known as: Minimally invasive treatment, Thermal ablation, Thermoablation

Patients will be treated with ultrasound-guided percutaneous cryoablation

Breast-conserving surgery PROCEDURE

Breast-conserving surgery

Also known as: Lumpectomy, Lumpectomie

Breast-conserving surgery

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Franciscus Gasthuis & Vlietland (Hospital): lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Transurethral Resection of Prostate; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Mastectomy

Study Officials

• T.M.A.L. GE Klem, MD, PhD

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Riks, MD

CONTACT

010 - 893 6010; l.riks@franciscus.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a multicenter randomized phase III non-inferiority trial with two arms: percutaneous cryoablation and breastconserving surgery. The randomization ratio is 1:1, stratified by center, tumor size (\< / \> 1 cm) and Bloom Richardson grade. All eligible patients will consecutively be included and randomized. Crossover is only possible for patients allocated to the cryoablation arm.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2038
• Last Updated: March 19, 2026

Record last verified: 2026-03