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

Starting soon · Not applicable

Conditions studied: Breast Cancer Stage I, Breast Cancer Early Stage Breast Cancer (Stage 1-3)

In brief

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.

Key facts

Study ID

NCT07398118

Run by

St. Antonius Hospital

People needed

61

Starts

2026-04-01

Expected to finish

2028-06-30

Last updated by the study team

2026-03-23

Who can join

Age: 70 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 70 years
• Histologically confirmed invasive breast cancer
• Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status
• Presence of concurrent DCIS is allowed if limited to <25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component
• Unifocal disease <2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall
• Ability and willingness to comply with project requirements
• Preoperative endocrine therapy is allowed
• Written informed consent given by the subject

You may not qualify if…

• Pure DCIS lesions without invasive component
• Extensive calcifications on imaging suggestive of widespread disease
• Invasive lobular carcinoma (as assessed by IHC)
• Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)
• History of ipsilateral breast cancer or DCIS
• Prior ipsilateral radiotherapy
• Inability to communicate in Dutch or English language
• Planned (e)migration or long-term stay abroad within one year after inclusion

Where it is running

• Rijnstate Hospital — Arnhem, Gelderland, Netherlands
• Amphia Hospital — Breda, North Brabant, Netherlands
• Antoni van Leeuwenhoek - Nederlands Kanker Instituut — Amsterdam, North Holland, Netherlands

Full record on ClinicalTrials.gov

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