CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age70+
SponsorSt. Antonius Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Cryoablation / Cryotherapy
Procedure/SurgeryCryoablation 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.
Treatment groups
61 Participants
are divided into 1 treatment groupGroup A: CryoablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 6 months after cryoablationSecondary outcomes
1
Technical success of cryoablation
Technical success is defined as correct placement of the cryoprobe(s) and completion of the planned freeze-thaw cycles resulting in complete coverage of the target tumour.
Time frame
During the cryoablation procedure2
Local tumour control
Local tumour control is defined as absence of residual or recurrent tumour at the treated site based on imaging and clinical follow-up.
Time frame
Up to 12 months after cryoablation3
Patient-reported tolerance and quality of life
Participant-reported tolerance of the procedure and health-related quality of life assessed using validated questionnaires.
Time frame
Baseline and up to 12 months after cryoablation4
Need for additional locoregional treatment
The proportion of participants requiring additional breast surgery or other locoregional treatment following cryoablation.
Time frame
Up to 12 months after cryoablationSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
Amphia Hospital
Collaborator
Rijnstate Hospital
Collaborator
Antoni van Leeuwenhoek Hospital
Collaborator
Source ClinicalTrials.gov
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