Metastatic Breast CancerCRYO-TOUCHNCT07676344
CRYO-TOUCH: Cryoablation of the Primary Breast Tumor in Metastatic Breast Cancer
A study testing Cryoablation and Patient-Reported Outcome Assessment in people with Metastatic Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Cryoablation and Patient-Reported Outcome Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 Jan 2030
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged ≥18 years.
- Histologically confirmed metastatic breast carcinoma, regardless of histological subtype, hormone receptor status, HER2 status, or tumor grade.
- Receiving systemic anticancer treatment for metastatic breast cancer, including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, or combination regimens.
- Clinical response or stable disease according to RECIST v1.1 on the most recent imaging assessment performed within 3 months before enrollment, except for the primary breast lesion, which may be progressing.
- Eligible for cryoablation of the primary breast tumor:
- ECOG Performance Status ≤2.
- Effective contraception for women of childbearing potential.
- Able and willing to provide written informed consent.
Who cannot join
- Contraindication to cryoablation according to the investigator and/or interventional radiologist.
- Contraindication to gadolinium-enhanced breast MRI according to institutional practice and radiologist assessment.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical study with an ongoing exclusion period or that could interfere with the present study according to investigator judgment.
- Psychiatric disorder or any medical condition that, in the opinion of the investigator, could compromise study participation or compliance with study procedures.
- Adults under legal protection or unable to provide informed consent.
- Persons deprived of liberty by judicial or administrative decision.
- Absence of health insurance coverage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Lyon-Sud
Lyon, 69 495
Julien PERON, PR, 4 78 86 43 18 ext. +33, julien.peron@chu-lyon.fr
About this study
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Read the detailed description
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.
Preliminary retrospective data and local clinical experience suggest that cryoablation of the primary breast tumor may be feasible, safe, and associated with favorable local control in selected patients with metastatic breast cancer. Additional prospective data are needed to better characterize its clinical outcomes and its potential role as an alternative local treatment option.
The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Secondary objectives include evaluation of procedure-related safety, postoperative complications, pain, quality of life, treatment interruption, and implementation outcomes such as acceptability, appropriateness, feasibility, fidelity, and sustainability among both patients and healthcare professionals.
The study hypothesizes that cryoablation of the primary breast tumor is associated with satisfactory local tumor control, acceptable safety, favorable quality of life outcomes, and high acceptability among patients and healthcare professionals.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Cryoablation, Patient-Reported Outcome Assessment
- Keywords
- Metastatic Breast Cancer, Cryoablation, Interventional Radiology, Local Tumor Control, Quality of Life, Implementation Science, Breast-Q, Minimally Invasive Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Participants with metastatic breast cancer and an eligible primary breast tumor undergoing cryoablation as part of their clinical management. Participants will undergo cryoablation of the primary breast tumor and will be followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI assessments, pain evaluations, quality-of-life questionnaires, safety assessments, and implementation questionnaires.
Patient-Reported Outcome AssessmentOther
Assessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Other | Participants with metastatic breast cancer and an eligible primary breast tumor undergoing cryoablation as part of their clinical management. Participants will undergo cryoablation of the primary breast tumor and will be followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI assessments, pain evaluations, quality-of-life questionnaires, safety assessments, and implementation questionnaires. Receives: Procedure: Cryoablation; Other: Patient-Reported Outcome Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Breast Tumor Recurrence at 12 Months
Presence of ipsilateral breast tumor recurrence (IBTR) 12 months after cryoablation of the primary breast tumor. IBTR is defined as invasive local recurrence identified on breast MRI and, when indicated, confirmed by biopsy.
Measured: 12 months after cryablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center prospective cohort study. Eligible patients undergoing cryoablation of the primary breast tumor as part of routine clinical care will be enrolled and followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI examinations, patient-reported outcome measures, pain assessments, safety monitoring, and implementation questionnaires.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676344
- Sponsor's protocol ID
- 69HCL25_0566
- Acronym
- CRYO-TOUCH
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRYO-TOUCH: Cryoablation of the Primary Breast Tumor in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07676344
- Acronym / sponsor ID
- CRYO-TOUCH / 69HCL25_0566
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Cryoablation, Interventional Radiology, Local Tumor Control, Quality of Life, Implementation Science, Breast-Q, Minimally Invasive Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 30 Jun 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.
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Detailed description
Metastatic breast cancer remains an incurable disease for most patients. While surgical treatment of the primary breast tumor is commonly performed in localized breast cancer, its role in metastatic breast cancer remains controversial due to the lack of demonstrated survival benefit and the potential interruption of systemic anticancer therapies.
Cryoablation is a minimally invasive outpatient procedure that destroys tumor tissue through controlled freezing. In localized breast cancer, cryoablation has shown promising results regarding local tumor control, safety, and patient quality of life. However, evidence regarding its use in metastatic breast cancer remains limited.
Preliminary retrospective data and local clinical experience suggest that cryoablation of the primary breast tumor may be feasible, safe, and associated with favorable local control in selected patients with metastatic breast cancer. Additional prospective data are needed to better characterize its clinical outcomes and its potential role as an alternative local treatment option.
The primary objective of this prospective single-center cohort study is to evaluate local tumor control 12 months after cryoablation of the primary breast tumor in patients with metastatic breast cancer.
Secondary objectives include evaluation of procedure-related safety, postoperative complications, pain, quality of life, treatment interruption, and implementation outcomes such as acceptability, appropriateness, feasibility, fidelity, and sustainability among both patients and healthcare professionals.
The study hypothesizes that cryoablation of the primary breast tumor is associated with satisfactory local tumor control, acceptable safety, favorable quality of life outcomes, and high acceptability among patients and healthcare professionals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center prospective cohort study. Eligible patients undergoing cryoablation of the primary breast tumor as part of routine clinical care will be enrolled and followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI examinations, patient-reported outcome measures, pain assessments, safety monitoring, and implementation questionnaires.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Other | Procedure: Cryoablation, Other: Patient-Reported Outcome AssessmentParticipants with metastatic breast cancer and an eligible primary breast tumor undergoing cryoablation as part of their clinical management. Participants will undergo cryoablation of the primary breast tumor and will be followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI assessments, pain evaluations, quality-of-life questionnaires, safety assessments, and implementation questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female aged ≥18 years.
- Histologically confirmed metastatic breast carcinoma, regardless of histological subtype, hormone receptor status, HER2 status, or tumor grade.
- Receiving systemic anticancer treatment for metastatic breast cancer, including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, or combination regimens.
- Clinical response or stable disease according to RECIST v1.1 on the most recent imaging assessment performed within 3 months before enrollment, except for the primary breast lesion, which may be progressing.
- Eligible for cryoablation of the primary breast tumor:
Key exclusion criteria (8 listed)
- Contraindication to cryoablation according to the investigator and/or interventional radiologist.
- Contraindication to gadolinium-enhanced breast MRI according to institutional practice and radiologist assessment.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical study with an ongoing exclusion period or that could interfere with the present study according to investigator judgment.
- Psychiatric disorder or any medical condition that, in the opinion of the investigator, could compromise study participation or compliance with study procedures.
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 |
|---|---|---|
| CryoablationParticipants with metastatic breast cancer and an eligible primary breast tumor undergoing cryoablation as part of their clinical management. Participants will undergo cryoablation of the primary breast tumor and will be followed for 12 months. Study-specific procedures include baseline and 12-month breast MRI assessments, pain evaluations, quality-of-life questionnaires, safety assessments, and implementation questionnaires. | Procedure or surgery | Cryoablation |
| Patient-Reported Outcome AssessmentAssessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation. | Other | Cryoablation |
Primary outcome
Ipsilateral Breast Tumor Recurrence at 12 Months
Time frame: 12 months after cryablation
Presence of ipsilateral breast tumor recurrence (IBTR) 12 months after cryoablation of the primary breast tumor. IBTR is defined as invasive local recurrence identified on breast MRI and, when indicated, confirmed by biopsy.
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 30 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and Patient-Reported Outcome Assessment in people with Metastatic Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Julien PERON, MD (4 78 86 43 18 ext. +33, julien.peron@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Breast Tumor Recurrence at 12 Months (time frame: 12 months after cryablation). 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 30 Jun 2026.