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.
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.
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.
Single group
Cryoablation
Procedure/SurgeryParticipants 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 Assessment
Other interventionAssessment of patient-reported outcomes including quality of life (BREAST-Q questionnaire), pain evaluation, and patient experience questionnaires evaluating acceptability and appropriateness of cryoablation.
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.
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