ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
Condition(s) studied
Investigational drug(s) / intervention(s)
blood sample for Signatera (TM) test: ctDNA: Evaluation of ctDNA-status prior to treatment start (ctDNA not detected or ctDNA-positive) until the last of five follow-up visit
biopsy for Ki-67 assessment: Ki67: Evaluation of Ki-67-value after 3 weeks of aromatase inhibitor
FFPE tumor sample for Signatera (TM) test (archived): Evaluation of ctDNA status prior to treatment start
Study summary
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 treatment arms of the Main Treatment Phase, depending on SignateraTM test result and Ki-67 value after 3 weeks of AI therapy (see "detailed description" for details).
* Visit the clinic for checkups and tests at timepoints:
* Prior to starting trial treatment
* 3 weeks after start of endocrine treatment in the Run-in phase
* Approx. 1 week later, prior to start of Main Treatment
* After half of the therapy in the Main Therapy Phase has been completed
* Once Main Treatment Phase treatment is complete (after 7-9 months overall)
* For surgery and post-surgery checkup
* Annually during the 5 years follow-up phase after surgery.
* A subset of patients, who receive adjuvant chemotherapy after surgery, are asked to come to site for an additional visit after completion of chemotherapy.
* Provide blood samples for ctDNA-assessment and future research when visiting the clinic
* Answer patient-reported questionnaires about their quality of life, symptoms and sexual health
Eligibility
Primary outcome measure(s)
- Modified PEPI (Preoperative Endocrine Prognostic Index) score — From randomization to the timepoint of surgery
The proportions of patients with a modified PEPI score of 0 are compared between treatment arm A and treatment arm B. The score ranges between 0 and 12 with 0 indicating the lowest risk of relapse.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Allg. Gynäkologie u. gyn. Onkologie/Senologie | Vienna | Austria | Recruiting |
| Landesklinikum Baden BGZ; Abt. f. Allgemein- u. Viszeralchirurgie | Baden | Austria | Recruiting |
| Dornbirn BGZ; Frauenheilkunde u. Geburtshilfe | Dornbirn | Austria | Active Not Recruiting |
| Landeskrankenhaus Feldkirch Interne E | Feldkirch | Austria | Recruiting |
| MUG - LKH Graz Klin. Abt. f. Onkologie | Graz | Austria | Recruiting |
| MUG - Univ. Frauenklinik Graz, Gyn. Abteilung | Graz | Austria | Recruiting |
| MUI - Univ. Klinik f. Frauenheilkunde Innsbruck Klin. Abteilung f. Gynäkologie u. Geburtshilfe | Innsbruck | Austria | Recruiting |
| TumorZentrum Kepler Universitätsklinikum Linz | Linz | Austria | Recruiting |
| LKH Salzburg - PMU, Univ.Klinik f. Innere Medizin III / SCRI CCCIT | Salzburg | Austria | Recruiting |
| Universitätsklinikum St. Pölten, Klin. Abteilung f. Innere Medizin 1 | Sankt Pölten | Austria | Recruiting |
| KH BHB St. Veit/Glan Brustzentrum Kärnten | Sankt Veit an der Glan | Austria | Active Not Recruiting |
| Hanusch Krankenhaus, 3. Medizinische Abteilung | Vienna | Austria | Recruiting |
| Klinik Hietzing, Gyn. Abteilung; Karl Landsteiner Institut f. gyn. Onkologie u. Senologie | Vienna | Austria | Recruiting |
| Universitätsklinikum Wiener Neustadt, Abteilung für Innere Medizin, Hämatologie und int. Onkologie | Wiener Neustadt | Austria | Recruiting |
More Austrian Breast & Colorectal Cancer Study Group trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07084558 on ClinicalTrials.gov ↗ ← All trials in Austria