28615 – CRYOABLATION IN THE TREATMENT OF EARLY BREAST CANCER: RESULTS FROM THE STUDY FREEZING BREAST CANCER IN BRAZIL (FIRST)

Abstract

Introduction: Image-guided tumor ablation is a minimally invasive, non-surgical therapy available for local treatment
of carcinomas, offering an alternative to surgery. However, studies evaluating this therapy in early breast cancer have
reported variable success rates, raising the question of whether omitting surgery is a viable option. Ongoing studies, such
as the FROST and ICE3 trials, may alter the landscape of cryoablation in the treatment of early breast cancer. In the era
of minimally invasive treatment, the search for ablative therapies like cryoablation has emerged as a treatment option.
Methodology: This is a multicenter, non-randomized, single-arm, before-and-after clinical trial. Inclusion criteria include
patients with unifocal invasive breast carcinoma, tumors ≤2.5 cm, lesions visualized by ultrasound, and surgery indicated
as the primary treatment option. Exclusion criteria include ductal carcinoma in situ, multifocal or multicentric tumors,
clinical axillary involvement, lesion-to-skin distance less than 5 mm, presence of distant metastases, and neoadjuvant
treatment. All patients will undergo local cryoablation followed by conventional surgical treatment 14 to 28 days later.
Imaging exams (mammography, ultrasound, and breast MRI) will be performed before and after ablation. The efficacy of
cryoablation will be assessed based on the success rate, defined as the absence of malignant neoplastic cells, both invasive
and in situ, in the surgical specimen. If the expected success rate of cryoablation is similar to the 92% rate reported in the
ACOSOG Z1072 study for patients without multifocal disease, a minimum of 32 patients will be necessary to determine
if the technique is satisfactory (success rate >70%), with 95% statistical power and a 5% significance level. This study was
approved by the local Ethics Committee and registered on ClinicalTrials.gov (NCT05398497). Conclusion: The results
highlight cryoablation as a promising therapy, providing a viable alternative to surgical approaches in patients with early-
-stage breast cancer, as demonstrated in this study. The ongoing advancement of minimally invasive therapies consolidates cryoablation as an option in the treatment of early breast cancer.