Abstract OT-04-02: The AXSANA trial (AXillary Surgery After NeoAdjuvant treatment): An international prospective multicenter cohort study of the EUBREAST study group to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655)
Authors: Banys-Paluchowski Maggie , Stickeler Elmar , de Boniface Jana , Gentilini Oreste , Thill Marc , Hartmann Steffi , Mangold Marina , Solbach Christine , Blohmer Jens-Uwe , Untch Michael , Appelgren Matilda , Kolberg Hans-Christian , Kühn Thorsten ,   EUBREAST
Published: February 2021

Background

The optimal surgical staging of the axilla in patients who convert from a clinically positive (cN+) to a clinically negative node status (ycN0) through neoadjuvant chemotherapy is still unclear. Widely diverse techniques such as full Axillary Lymph Node Dissection (ALND), Targeted Axillary Dissection (TAD), Targeted Lymph Node Biopsy (TLNB) and Sentinel Lymph Node Biopsy alone (SLNB) are given preference in different international guidelines. So far, no comparative data on the oncological outcome or the morbidity of the different procedures are available. Further research is needed to safely de-escalate the radicality of axillary surgery in this patient group.

Trial design

The EUBREAST study group initiated an international prospective cohort study including cN+ patients converting to ycN0 status and treated with different axillary staging techniques according to the standard at their treating institution. Participants are patients with cT1-3 tumors with axillary lymph node metastasis confirmed by core biopsy or fine needle aspiration and scheduled for neoadjuvant systemic therapy. The trial is funded by the AGO-B Study Group, the Claudia von Schilling Foundation for Breast Cancer Research and the AWOgyn (Working Group for Reconstructive Surgery in Oncology-Gynecology) and supported by the NOGGO (North-Eastern German Society of Gynaecologic Oncology) and the German Breast Group.

Primary endpoints: 5-year invasive disease-free survival, 3-year axillary recurrence rate and health-related quality of life (HRQoL). HRQoL will be evaluated using four standardized questionnaires (EORTC QLQ-C 30, EORTC QLQ BR 23, Lymph ICF and SOC-13) at baseline and 1, 3 and 5 years after surgery.

Secondary endpoints are the feasibility and performance of different axillary staging techniques (detection rate, number of removed lymph nodes and association with complications, arm morbidity and quality of life, operating time and use of clinical and economic resources); impact of learning curve, and the detailed mapping of surgical and oncological treatment standards in different countries.

Present accrual (July 7th 2020): 5. The first study participant has been recruited in June 2020.

Target accrual: 3000 patients from EUBREAST member states (20)

Citation Format: Maggie Banys-Paluchowski, Elmar Stickeler, Jana de Boniface, Oreste Gentilini, Marc Thill, Steffi Hartmann, Marina Mangold, Christine Solbach, Jens-Uwe Blohmer, Michael Untch, Matilda Appelgren, Hans-Christian Kolberg, Thorsten Kühn, EUBREAST. The AXSANA trial (AXillary Surgery After NeoAdjuvant treatment): An international prospective multicenter cohort study of the EUBREAST study group to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-04-02.