About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cryoablation
- Patient-Reported Outcome Assessment