Radiofrequency Ablation in Breast Cancer

Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer. Our main objective is to evaluate the usefulness of RFA in \< 2cm malignant breast tumors to reduce the proportion of positive margins. Methodology: The investigator propose a single-center, single-blind, phase I and II randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the potential adverse effects in three stages: initial,intermediate and final. Phase II: Randomized clinical trial, 2 parallel groups with 37 patients in each one. Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group: conventional surgery with lumpectomy. The number of positive margins in both groups, and the need of extending margin resection will be assessed intraoperatively. Inclusion criteria: women \>40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique, visible by ultrasound, smaller than 2cm and located \> 1 cm from the chest wall and the skin. Patients will be followed up for a period of two years to assess cosmetic result, short -term and long -term complications and recurrences. Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk of intraoperative extensions for positive margins during lumpectomy compared to conventional surgery in breast tumors with a diameter \< 2 cm. Therefore this procedure may reduce the risk of second surgeries and the removed volume of tissue.Consequently the final cosmetic result should be improved.

Sex

Female

Minimum age

40 Years

Inclusion Criteria:

* Breast single tumor,
* Clearly visible by ultrasound,
* Diameter \< 2 cm
* Located \>1 cm from the chest wall and skin;
* Ductal carcinoma according to previous biopsy,
* \< 20% of intraductal carcinoma

Exclusion Criteria:

* Breast cancer in men;
* Personal history of ipsilateral breast cancer;
* Age \<40 years;
* Pregnancy or breastfeeding;
* Suspicion of intraductal extension or multifocality by mammography or MRI;
* Tumour not visible by ultrasound;
* Diameter \> 2 cm;
* Distance to muscle or skin \<1 cm;
* Lobular carcinoma;
* Intraductal carcinoma in \> 20% of the biopsy sample
* Patients undergoing neoadjuvant chemotherapy or hormonotherapy.

• DERIVEDGarcia-Tejedor A, Guma A, Soler T, Valdivieso A, Petit A, Contreras N, Chappuis CG, Falo C, Pernas S, Amselem A, Pla MJ, Fernandez-Montoli E, Burdio F, Ponce J. Radiofrequency Ablation Followed by Surgical Excision versus Lumpectomy for Early Stage Breast Cancer: A Randomized Phase II Clinical Trial. Radiology. 2018 Nov;289(2):317-324. doi: 10.1148/radiol.2018180235. Epub 2018 Aug 21. PMID 30129904