Dornbirn

Researchers are investigating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early or locally advanced estrogen receptor-positive and HER2-negative breast cancer who have no detectable circulating tumor DNA ctDNA before treatment and show endocrine responsiveness. This phase II performance study focuses on comparing these treatments effectiveness, measured by the modified preoperative endocrine prognostic index PEPI score at surgery, while also considering quality of life outcomes. Participants first provide blood and tumor samples for ctDNA assessment using the SignateraTM test. They then receive aromatase inhibitor AI therapy for 4 weeks during a Run-in phase, with a tumor biopsy after 3 weeks to evaluate Ki-67 levels. Based on ctDNA results and Ki-67 values, participants are assigned to one of three groups neoadjuvant AI or tamoxifen if AI is not tolerated for responders, or chemotherapy for non-responders. The Main Treatment Phase lasts 6 to 8 months, followed by surgery and a 5-year follow-up period. Throughout the study, participants attend multiple clinic visits for checkups, blood draws for ctDNA monitoring, and questionnaires about quality of life, symptoms, and sexual health. Key assessment points include before treatment start, after 3 weeks of AI therapy, prior to the Main Treatment Phase, mid-therapy, post-treatment, surgery, and annual follow-ups. Some participants receiving adjuvant chemotherapy have an additional visit after completing chemotherapy. The study evaluates several outcomes including PEPI score, residual cancer burden, survival measures, and breast conservation rates.

Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.

Researchers are studying metastatic breast cancer, the most common cancer among women worldwide, with a focus on patients in Austria. This study is the first Austrian-wide registry to systematically collect and document data on metastatic breast cancer cases. The aim is to understand epidemiological trends and treatment patterns, including tumor characteristics and patient outcomes. The study collects both retrospective and prospective data from multiple centers across Austria. It records detailed information on tumor subtypes, initial disease progression, treatment sequences, and patient medical histories. This registry also includes data on male breast cancer patients to assess gender differences in treatment and outcomes. Participants provide anonymized medical information, including tumor characteristics, treatment details, and survival data. Researchers will analyze patterns of metastasis, treatment responses, and survival rates at 1, 2, and 5 years after metastasis diagnosis. The registry aims to offer insights into treatment quality and outcomes over a 10-year period.