Menu
Not yet recruiting NCT07483996

Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

Phase III Interventional Early-Stage Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous cryoablation, Breast-conserving surgery.
Who it may be relevant to
Registry conditions: Early-Stage Breast Cancer. Basic parameters: from 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Percutaneous cryoablation
    In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.
  • Procedure Breast-conserving surgery
    Breast-conserving surgery

Primary outcome measures

  • Ipsilateral breast cancer recurrence [Time frame: Until 5 years after the intervention]
Secondary outcome measures (12)
  • Complication Rate [Time frame: Within 30 days after the intervention]
  • Regional breast cancer recurrences [Time frame: Until 5 years after the intervention]
  • Disease Free Survival [Time frame: until 15 years after the intervention]
  • Overall Survival [Time frame: through study completion, an average of 15 years]
  • Cosmetic Outcomes [Time frame: at baseline, 6 months and 1 year after the intervention]
  • Hospital-related costs [Time frame: Until 5 years after the intervention]
  • Out-of-hospital (non)-medical costs [Time frame: Until 5 years after the intervention]
  • Generic Health-related Quality of Life [Time frame: At baseline, 6 months after the intervention, 1 and 5 years after the intervention]
  • Disease-specific quality of life [Time frame: At baseline, 6 months after the intervention, 1 and 5 years after the intervention]
  • Complete ablation rate [Time frame: 2 weeks after the intervention (cryoablation)]
  • Predictive value of MRI [Time frame: until 5 years after the intervention]
  • Proportion of reinterventions [Time frame: For the duration of the study, most likely within 2 weeks after the intervention]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07483996 · NL-010714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗