Condition: Early and Locally Advanced Breast Cancer · Sponsor: Austrian Breast & Colorectal Cancer Study Group
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early and locally advanced ER+/HER2-negative breast cancer and no detectable ctDNA in peripheral blood. The main question it aims to answer is: Is neoadjuvant endocrine therapy at least equivalent to neoadjuvant chemotherapy for treatment of patients with ER-positive, HER2-negative breast cancer with no detectable ctDNA (as assessed with the SignateraTM test) prior to treatment start and a Ki-67-value smaller or equal to 10% after 3 weeks of initial aromatase inhibitor treatment (=endocrine responsive). Researchers will compare neoadjuvant Standard of Care aromatase inhibitors (AI) or tamoxifen, if AI is not tolerated, with neoadjuvant Standard of Care chemotherapy to see if treatment efficacy is at least comparable between the treatment arms, when measured with the modified preoperative endocrine prognostic index (PEPI) score at surgery. Participants will: * Provide blood and tumor samples for ctDNA-assessment with the SignateraTM test by Natera prior to treatment starts * Take AI therapy for 4 weeks in the initial Run-in phase * Undergo tumor biopsy after 3 weeks of AI for local evaluation of Ki-67 * Receive either 8 months of neoadjuvant Standard of Care AI/ tamoxifen or 6-8 months of neoadjuvant Standard of Care chemotherapy in one of the three tre…
This description comes directly from the study's public registry record.
Katharina Jarolim, PhD · +43 1 4089230 · katharina.jarolim@abcsg.at
Always discuss trial participation with your own doctor first.
| Allg. Gynäkologie u. gyn. Onkologie/Senologie | Vienna, Austria, Austria | Recruiting |
| Landesklinikum Baden BGZ; Abt. f. Allgemein- u. Viszeralchirurgie | Baden, Austria | Active Not Recruiting |
| Dornbirn BGZ; Frauenheilkunde u. Geburtshilfe | Dornbirn, Austria | Active Not Recruiting |
| Landeskrankenhaus Feldkirch Interne E | Feldkirch, Austria | Active Not Recruiting |
| MUG - LKH Graz Klin. Abt. f. Onkologie | Graz, Austria | Active Not Recruiting |
| MUG - Univ. Frauenklinik Graz, Gyn. Abteilung | Graz, Austria | Active Not Recruiting |
| MUI - Univ. Klinik f. Frauenheilkunde Innsbruck Klin. Abteilung f. Gynäkologie u. Geburtshilfe | Innsbruck, Austria | Recruiting |
| TumorZentrum Kepler Universitätsklinikum Linz | Linz, Austria | Active Not Recruiting |
| LKH Salzburg - PMU, Univ.Klinik f. Innere Medizin III / SCRI CCCIT | Salzburg, Austria | Not Yet Recruiting |
| Universitätsklinikum St. Pölten, Klin. Abteilung f. Innere Medizin 1 | Sankt Pölten, Austria | Active Not Recruiting |
| KH BHB St. Veit/Glan Brustzentrum Kärnten | Sankt Veit an der Glan, Austria | Active Not Recruiting |
| Hanusch Krankenhaus, 3. Medizinische Abteilung | Vienna, Austria | Active Not Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07084558