Clinical trial · Interventional
CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.
Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation / Cryotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryoablation
- description
- 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.
- interventionNames
- Procedure: Cryoablation / Cryotherapy
Primary outcomes (1)
- measure
- Feasibility and acute safety of cryoablation
- timeFrame
- Up to 6 months after cryoablation
- description
- 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).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
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