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

Overview

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.

Interventions

• Procedure Cryoablation
  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.
• Other Patient-Reported Outcome Assessment
  Assessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation.

Primary outcome measures

• Ipsilateral Breast Tumor Recurrence at 12 Months [Time frame: 12 months after cryablation]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Centre Hospitalier Lyon-Sud — Lyon

Identifiers

NCT: NCT07676344 · 69HCL25_0566

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗