Breast Cancer Stage ICRYO-1NCT07398118
CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.
A study testing Cryoablation / Cryotherapy in people with Breast Cancer Stage I and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by St. Antonius Hospital at 3 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Cryoablation / Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Apr 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites
Antoni van Leeuwenhoek - Nederlands Kanker Instituut
Amsterdam, North Holland, 1066 CX
Frederieke van Duijnhoven, MD, PhD, +31619874388, f.v.duijnhoven@nki.nl
Rijnstate Hospital
Arnhem, Gelderland, 6836 BH
Ramon van Eekeren, MD, PhD, +3164824542, rvaneekeren@rijnstate.nl
Amphia Hospital
Breda, North Brabant, 4818 CK
Eliane CM Zeestraten, MD, PhD, +3123421369, EZeestraten@amphia.nl
About this study
Official title: Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.
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.
Read more
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.
Read the detailed description
CRYO-1 is a multicentre, phase II, single-arm interventional feasibility study evaluating cryoablation as a primary treatment for older adults with early-stage breast cancer. The study includes participants aged 70 years or older with clinically node-negative (cT1N0), estrogen receptor-positive, HER2-negative invasive breast cancer.
Standard treatment for this patient population consists of surgery or primary endocrine therapy. Although effective, both approaches may be associated with treatment burden in older adults. Surgical treatment may result in perioperative morbidity, while primary endocrine therapy requires prolonged treatment and may be associated with side effects and the development of endocrine resistance. Cryoablation is a minimally invasive, image-guided technique that induces tumour destruction by freezing and may reduce treatment burden in selected patients.
In this study, cryoablation is performed percutaneously under imaging guidance as a single procedure, without surgical excision of the primary tumour. The intervention is investigated as an alternative local treatment strategy in this selected population.
The primary objective of CRYO-1 is to assess feasibility and acute safety of cryoablation. Feasibility is defined by successful completion of the procedure, and safety is assessed by the incidence of treatment-related adverse events within three months, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Secondary objectives include technical success, need for additional locoregional treatment, early local tumour control, patient tolerance, and health-related quality of life. Exploratory objectives include longer-term oncologic outcomes and identification of factors associated with successful local control.
CRYO-1 is an investigator-initiated study conducted across multiple hospitals. All participants provide written informed consent prior to enrolment. The study aims to generate prospective evidence on the feasibility and safety of cryoablation in older adults with early-stage breast cancer and to inform the design of future comparative or de-escalation studies.
- Being tested
- Cryoablation / Cryotherapy
- Keywords
- Cryoablation, Early-stage breast cancer, Non-curative, Elderly, Minimally invasive treatment, Breast tumour, Local tumour control, Feasibility study, Cryotherapy, Non-surgical treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation / CryotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | 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. Receives: Procedure: Cryoablation / Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months after cryoablation
Secondary outcomes (4)
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.
Measured: During the cryoablation procedure
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.
Measured: Up to 12 months after cryoablation
Patient-reported tolerance and quality of life
Participant-reported tolerance of the procedure and health-related quality of life assessed using validated questionnaires.
Measured: Baseline and up to 12 months after cryoablation
Need for additional locoregional treatment
The proportion of participants requiring additional breast surgery or other locoregional treatment following cryoablation.
Measured: Up to 12 months after cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-arm interventional model in which all participants undergo image-guided cryoablation as a one-time primary treatment. The study is designed to assess feasibility and safety in a selected population without randomisation or comparison to standard treatment.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amphia Hospital, Rijnstate Hospital, Antoni van Leeuwenhoek Hospital
- Responsible party
- Principal investigator, Iza Stekelenburg, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398118
- Sponsor's protocol ID
- R25.102
- Acronym
- CRYO-1
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.
- ClinicalTrials.gov ID
- NCT07398118
- Acronym / sponsor ID
- CRYO-1 / R25.102
- Keywords
- Cryoablation, Early-stage breast cancer, Non-curative, Elderly, Minimally invasive treatment, Breast tumour, Local tumour control, Feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Amphia Hospital, Rijnstate Hospital, Antoni van Leeuwenhoek Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CRYO-1 is a multicentre, phase II, single-arm interventional feasibility study evaluating cryoablation as a primary treatment for older adults with early-stage breast cancer. The study includes participants aged 70 years or older with clinically node-negative (cT1N0), estrogen receptor-positive, HER2-negative invasive breast cancer.
Standard treatment for this patient population consists of surgery or primary endocrine therapy. Although effective, both approaches may be associated with treatment burden in older adults. Surgical treatment may result in perioperative morbidity, while primary endocrine therapy requires prolonged treatment and may be associated with side effects and the development of endocrine resistance. Cryoablation is a minimally invasive, image-guided technique that induces tumour destruction by freezing and may reduce treatment burden in selected patients.
In this study, cryoablation is performed percutaneously under imaging guidance as a single procedure, without surgical excision of the primary tumour. The intervention is investigated as an alternative local treatment strategy in this selected population.
The primary objective of CRYO-1 is to assess feasibility and acute safety of cryoablation. Feasibility is defined by successful completion of the procedure, and safety is assessed by the incidence of treatment-related adverse events within three months, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Secondary objectives include technical success, need for additional locoregional treatment, early local tumour control, patient tolerance, and health-related quality of life. Exploratory objectives include longer-term oncologic outcomes and identification of factors associated with successful local control.
CRYO-1 is an investigator-initiated study conducted across multiple hospitals. All participants provide written informed consent prior to enrolment. The study aims to generate prospective evidence on the feasibility and safety of cryoablation in older adults with early-stage breast cancer and to inform the design of future comparative or de-escalation studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-arm interventional model in which all participants undergo image-guided cryoablation as a one-time primary treatment. The study is designed to assess feasibility and safety in a selected population without randomisation or comparison to standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: Cryoablation / CryotherapyParticipants 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation / CryotherapyCryoablation 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. | Procedure or surgery | Cryoablation |
Primary outcome
Feasibility and acute safety of cryoablation
Time frame: Up to 6 months after 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).
4 secondary outcomes
Technical success of cryoablation
Time frame: During the cryoablation procedure
Local tumour control
Time frame: Up to 12 months after cryoablation
Patient-reported tolerance and quality of life
Time frame: Baseline and up to 12 months after cryoablation
Need for additional locoregional treatment
Time frame: Up to 12 months after cryoablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation / Cryotherapy in people with Breast Cancer Stage I and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by St. Antonius Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iza Stekelenburg, MD (+31657835198, i.stekelenburg@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acute safety of cryoablation (time frame: Up to 6 months after cryoablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.