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CRYO-1
Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.
Sponsor study identifier
interventional
61
1 country
3
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2026
Actual (reported)February 9, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Feasibility and acute safety of cryoablation
Feasibility is defined as successful completion of the cryoablation procedure as planned. Acute safety is assessed by the incidence of treatment-related adverse events following cryoablation, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity is graded according to the CTCAE v5.0 grading system, which classifies adverse events on an ordinal scale from Grade 1 (mild) to Grade 5 (death related to adverse event). The minimum score is Grade 1 and the maximum possible score is Grade 5. Higher grades indicate more severe toxicity (worse outcome).
Up to 6 months after cryoablation
Technical success of cryoablation
During the cryoablation procedure
Participants receive image-guided percutaneous cryoablation as a single primary treatment for early-stage breast cancer. Cryoablation is performed to destroy the tumour by freezing, without surgical excision of the primary tumour.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rijnstate Hospital
Arnhem, Gelderland, 6836 BH, Netherlands
Amphia Hospital
Breda, North Brabant, 4818 CK, Netherlands
Antoni van Leeuwenhoek - Nederlands Kanker Instituut
Amsterdam, North Holland, 1066 CX, Netherlands
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Local tumour control
Up to 12 months after cryoablation
Patient-reported tolerance and quality of life
Baseline and up to 12 months after cryoablation
Need for additional locoregional treatment
Up to 12 months after cryoablation
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 23, 2026
Record last verified: 2026-03
Individual participant data will not be shared because the dataset contains sensitive health information, and data sharing was not included in the informed consent or study protocol. Data will be analysed by the study team in accordance with applicable data protection regulations.
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Source: ClinicalTrials.gov.
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