RecruitingNot ApplicableNCT07084558

ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness

ABCSG 61 / TEODOR (Neoadjuvant TrEatment Optimization Driven by ctDNA and endOcrine Responsiveness): A Prospective, Randomized, Controlled, Openlabel Multicenter Phase II Study Investigating Neoadjuvant Endocrine Therapy Versus Chemotherapy in HR-positive, HER2negative, ctDNA-negative and Endocrine Responsive Early and Locally Advanced Breast Cancer


Sponsor

Austrian Breast & Colorectal Cancer Study Group

Enrollment

350 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether measuring a cancer marker in the blood called circulating tumor DNA (ctDNA) during treatment can help doctors personalize hormone therapy for people with hormone receptor-positive, HER2-negative locally advanced breast cancer before surgery. **You may be eligible if...** - You are 18 or older (any gender) - You have been diagnosed with locally advanced breast cancer (Stage IIA to III) that is hormone receptor-positive and HER2-negative - You have not yet started treatment for this cancer - Your tumor meets specific hormone receptor thresholds **You may NOT be eligible if...** - You have already received chemotherapy or hormone therapy for this breast cancer - Your cancer has spread to other organs (distant metastases) - You have serious heart conditions or other significant health problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTblood 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

DIAGNOSTIC_TESTbiopsy for Ki-67 assessment

Ki67: Evaluation of Ki-67-value after 3 weeks of aromatase inhibitor

DIAGNOSTIC_TESTFFPE tumor sample for Signatera (TM) test (archived)

Evaluation of ctDNA status prior to treatment start


Locations(14)

Allg. Gynäkologie u. gyn. Onkologie/Senologie

Vienna, Austria, Austria

Landesklinikum Baden BGZ; Abt. f. Allgemein- u. Viszeralchirurgie

Baden, Austria

Dornbirn BGZ; Frauenheilkunde u. Geburtshilfe

Dornbirn, Austria

Landeskrankenhaus Feldkirch Interne E

Feldkirch, Austria

MUG - LKH Graz Klin. Abt. f. Onkologie

Graz, Austria

MUG - Univ. Frauenklinik Graz, Gyn. Abteilung

Graz, Austria

MUI - Univ. Klinik f. Frauenheilkunde Innsbruck Klin. Abteilung f. Gynäkologie u. Geburtshilfe

Innsbruck, Austria

TumorZentrum Kepler Universitätsklinikum Linz

Linz, Austria

LKH Salzburg - PMU, Univ.Klinik f. Innere Medizin III / SCRI CCCIT

Salzburg, Austria

Universitätsklinikum St. Pölten, Klin. Abteilung f. Innere Medizin 1

Sankt Pölten, Austria

KH BHB St. Veit/Glan Brustzentrum Kärnten

Sankt Veit an der Glan, Austria

Hanusch Krankenhaus, 3. Medizinische Abteilung

Vienna, Austria

Klinik Hietzing, Gyn. Abteilung; Karl Landsteiner Institut f. gyn. Onkologie u. Senologie

Vienna, Austria

Universitätsklinikum Wiener Neustadt, Abteilung für Innere Medizin, Hämatologie und int. Onkologie

Wiener Neustadt, Austria

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NCT07084558