CRYO-TOUCH: Cryoablation of the Primary Breast Tumor in Metastatic Breast Cancer

NCT07676344 | Not Yet Recruiting

• 1 other identifier: 69HCL25_0566
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Cryoablation; Interventional Radiology; Local Tumor Control; Quality of Life; Implementation Science; Breast-Q; Minimally Invasive Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after cryablation

Study Arms (1)

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.

Procedure: Cryoablation; Other: Patient-Reported Outcome Assessment

Interventions

Cryoablation PROCEDURE

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.

Cryoablation

Patient-Reported Outcome Assessment OTHER

Assessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation.

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon-Sud

Lyon, 69 495, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Julien PERON, MD

CONTACT

4 78 86 43 18; julien.peron@chu-lyon.fr

Thibaut REVERDY

CONTACT

4 78 86 43 18; thibaut.reverdy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

FR (1)