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NCT Number: NCT07483996

Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

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.

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Sufficient knowledge of the Dutch language to complete the questionnaires
  • To be able to give written informed consent

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
  • 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)

Treatment and study plan

Percutaneous cryoablation

Procedure

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

Other names: Minimally invasive treatment, Thermal ablation, Thermoablation

Breast-conserving surgery

Procedure

Breast-conserving surgery

Other names: Lumpectomy, Lumpectomie

Primary outcomes

  1. Ipsilateral breast cancer recurrence

    Time frame: Until 5 years after the intervention

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

Secondary outcomes

  1. Complication Rate

    Time frame: Within 30 days after the intervention

    The proportion of complications within 30 days (percentage Clavien-Dindo classification).

  2. Regional breast cancer recurrences

    Time frame: Until 5 years after the intervention

    Regional breast cancer recurrences, defined as clinically, radiologically, and/or histologically confirmed recurrence in regional lymph nodes.

  3. Disease Free Survival

    Time frame: until 15 years after the intervention

    Disease free survival (DFS) is defined as the time from date of intervention to the first occurrence of recurrent disease of the same histological characteristics as the primary tumor and in the same quadrant as the primary tumor

  4. Overall Survival

    Time frame: through study completion, an average of 15 years

    Overall survival (OS) is defined as the time from breast cancer diagnosis to death from any cause.

  5. Cosmetic Outcomes

    Time frame: at baseline, 6 months and 1 year after the intervention

    o assess cosmetic outcomes following treatment with cryoablation or lumpectomy using the BCTOS-13 and BREAST-Q questionnaires at specified follow-up visits, and objective assessment using BCCT.core software. Higher scores indicate better cosmetic outcomes.

  6. Hospital-related costs

    Time frame: Until 5 years after the intervention

    Hospital-related costs, including expenses made due to additional findings on inclusion MRI

  7. Out-of-hospital (non)-medical costs

    Time frame: Until 5 years after the intervention

    To assess out-of-hospital medical and non-medical costs and productivity losses using the iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) questionnaires.

  8. Generic Health-related Quality of Life

    Time frame: At baseline, 6 months after the intervention, 1 and 5 years after the intervention

    To assess general health-related quality of life using the EQ-5D-5L questionnaire, with higher scores indicating better health status

  9. Disease-specific quality of life

    Time frame: At baseline, 6 months after the intervention, 1 and 5 years after the intervention

    To assess cancer-specific quality of life using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Higher scores indicate better functioning or greater symptom burden depending on the subscale.

  10. Complete ablation rate

    Time frame: 2 weeks after the intervention (cryoablation)

    On magnetic resonance imaging

  11. Predictive value of MRI

    Time frame: until 5 years after the intervention

    The negative predictive-, and diagnostic value of MRI for incomplete ablation

  12. Proportion of reinterventions

    Time frame: For the duration of the study, most likely within 2 weeks after the intervention

    For both study arms.

  13. Radiation Toxicity

    Time frame: At baseline, prior to radiation, 1 year and 5 years after the intervention

    The proportion of acute and long-term breast irradiation toxicity (radiation dermatitis, superficial or deep connective tissue fibrosis, chest wall pain, localized edema) using common toxicity criteria (CTCAE v5.0) and cosmetic questionnaires

  14. Incremental cost-utility ratio (ICUR)

    Time frame: Until 5 years after the intervention

    To estimate the incremental cost-utility ratio (ICUR). Higher ICUR values indicate higher costs per quality-adjusted life year (QALY) gained.

Other outcomes

  1. Any other parameters

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

    To explore patient- or tumor-related factors that may influence complete ablation or surgical outcomes, including breast density and other relevant parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Riks, MD

CONTACT

[email protected]

010 - 893 6010

Sponsors and collaborators

Lead sponsor

Franciscus Gasthuis & Vlietland (Hospital)

Other

Registry information

Official study title

Cryoablation as Alternative for Lumpectomy in Early-Stage Breast Cancer: The CRYSTAL Trial

Acronym: CRYSTAL

Important dates

Study start
2026
Primary completion
2035
Study completion
2038
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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