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CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.

NCT07398118 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-03-23

No results posted yet for this study

Summary

This study looks at a new way to treat early-stage breast cancer in older adults using a freezing technique called cryoablation.

Older adults with early-stage breast cancer are usually treated with surgery or primary endocrine therapy (hormone therapy). While these treatments can be effective, they may also be burdensome. Surgery can lead to pain, slow recovery, or complications, and primary endocrine therapy often requires long-term medication and may cause side effects or stop working over time. Cryoablation may offer a less invasive treatment option.

The goal of this study is to find out whether cryoablation can be safely and successfully used as the main treatment for older adults with early-stage breast cancer. Cryoablation destroys the tumour by freezing it. The procedure is performed through the skin using imaging guidance and does not involve surgical removal of the tumour.

Participants in this study are adults aged 70 years or older who have a small breast tumour that has not spread to the lymph nodes. All participants receive cryoablation as a single treatment.

After the procedure, participants are followed closely. Researchers will collect information on side effects, recovery, whether additional treatment is needed, and how participants experience the treatment. Quality of life will also be assessed.

This study is carried out in several hospitals. All participants must give written informed consent before taking part. The results of this study may help determine whether cryoablation could be a safe and practical treatment option for older adults with early-stage breast cancer and guide future research.

Conditions

  • Breast Cancer Stage I
  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

PROCEDURE

Cryoablation / Cryotherapy

Cryoablation is performed as a percutaneous, image-guided procedure in which the breast tumour is destroyed by controlled freezing. One or more cryoprobes are placed into the tumour under imaging guidance, and freezing cycles are applied to achieve complete local tumour ablation. The procedure is performed as a single intervention without surgical excision of the primary tumour.

Sponsors & Collaborators

  • Amphia Hospital

    collaborator OTHER

  • Rijnstate Hospital

    collaborator OTHER

  • Antoni van Leeuwenhoek Hospital

    collaborator OTHER

  • St. Antonius Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398118 on ClinicalTrials.gov