Dornbirn

Researchers are evaluating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early and locally advanced estrogen receptor-positive (ER+), HER2-negative breast cancer who show no detectable circulating tumor DNA (ctDNA) in their blood and have a low Ki-67 value after initial therapy. This phase II, prospective, randomized, controlled, open-label study focuses on participants whose tumors respond to endocrine therapy, aiming to compare treatment effectiveness and quality of life outcomes between the two approaches. Participants first undergo a 4-week Run-in phase taking aromatase inhibitors (or tamoxifen if aromatase inhibitors are not tolerated) while providing blood and tumor samples for ctDNA assessment and Ki-67 analysis. Based on these results, they are assigned to one of three treatment arms: neoadjuvant endocrine therapy (aromatase inhibitors or tamoxifen), neoadjuvant chemotherapy, or chemotherapy if ctDNA is detected or Ki-67 is high. The main treatment phase lasts 6 to 8 months, followed by surgery. Throughout the study, participants attend clinic visits before treatment, during the Run-in phase, before the main treatment, mid-treatment, after completing therapy, at surgery and post-surgery, and annually for five years. They provide blood samples for ctDNA analysis, undergo biopsies, and complete questionnaires about quality of life, symptoms, and sexual health. The primary outcome measured is the modified Preoperative Endocrine Prognostic Index (PEPI) score from randomization to surgery.

Researchers are evaluating treatments for patients with clinically node positive breast cancer who undergo upfront surgery. The study aims to compare tailored axillary surgery (TAS) combined with axillary radiotherapy (ART) against the standard axillary lymph node dissection (ALND) to see which approach results in better arm-related quality of life and fewer cases of lymphedema two years after treatment. This trial addresses the concern that ALND, while standard, can cause significant harm and morbidity, and seeks to determine if TAS plus ART can reduce this burden. Participants are randomly assigned to receive either ALND, which involves surgical removal of lymphatic tissue in the armpit area, or the combination of TAS and ART. TAS targets positive lymph nodes more selectively than ALND and removes fewer nodes, while ART involves radiation treatment to the axillary region. The trial is conducted in the upfront surgery setting, with prior clipping of the most suspicious axillary lymph node to aid in treatment precision. During the study, participants will complete quality of life questionnaires and be closely monitored for the development of lymphedema over two years following randomization. The main outcomes measured are changes in arm-related quality of life and the occurrence of lymphedema. Safety and treatment effects will be tracked through regular follow-up visits, with the overall goal of improving patient well-being and reducing treatment-related side effects.

Breast cancer is the most common cancer among women worldwide, with over 5,000 new cases diagnosed annually in Austria. At diagnosis, 5% to 10% of these patients already have distant metastases, and metastasis can develop later in many others depending on lymph node involvement. This study is the first Austrian-wide medical registry to systematically document metastatic breast cancer, aiming to answer epidemiological and treatment-related questions by collecting detailed patient and tumor data. The registry collects both prospective and retrospective data from multiple centers across Austria. It records all tumor characteristics, medical histories, and treatment sequences in anonymized form. The study assesses initial disease progression, tumor characteristics, treatment strategies, and survival outcomes over time. It also evaluates the distribution and characteristics of metastatic breast cancer in male patients and analyzes survival rates at 1, 2, and 5 years after metastasis diagnosis. Participants provide data on histological and radiological evidence of metastases, tumor subtype, treatment history, and disease progression. Researchers monitor overall survival and the frequency of prognostic factors for metastatic breast cancer over a 10-year period. The registry also tracks the influence of gender on treatment approaches and the response to therapies in real-life settings. This comprehensive documentation supports understanding of metastatic breast cancer in Austria and informs future treatment strategies.