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Recruiting Not applicable

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

NCT07084558 · tracked via the Priya Life Science Austria tracker
Phase
Not applicable
Started
2025-08-13
Last updated
2026-08-19

Condition(s) studied

Early and Locally Advanced Breast Cancer

Investigational drug(s) / intervention(s)

blood sample for Signatera (TM) testbiopsy for Ki-67 assessmentFFPE tumor sample for Signatera (TM) test (archived)

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent obtained prior to any study specific assessments and procedures 2. Women and men of age ≥18 years 3. Patients must have histologically confirmed invasive, unilateral and locally advanced breast cancer with the following characteristics: * Stage IIA-III per AJCC (American Joint Committee on Cancer) Breast Cancer Staging version 8 * Histologically confirmed hormone receptor positive and HER2 negative tumor(s); HER2 measurement to be assessed locally according to the ASCO/CAP guidelines. In case the tumor is multicentric and/or multifocal, all histopathologically examined tumors must meet the pathologic criteria for hormone receptor positive and HER2 negative * ER positive tumors, i.e. \>20% positive stained tumor cells * PR positive or negative tumors 4. Systemic chemotherapy indicated by multidisciplinary tumor board 5. Absence of prior breast cancer specific treatment for the current malignancy when entering screening 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Adequate bone marrow and organ function as defined by the following local laboratory values within 8 weeks before study treatment start: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L 2. Platelets ≥ 100 × 109/L 3. Hemoglobin ≥ 10.0 g/dL 4. Serum creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m² for patients with serum creatinine levels above institutional ULN. 5. Alanine amino transferase (ALT or SGPT) ≤ 1.5 × Upper Limit Normal (ULN); Aspartate amino transferase (AST or SGOT) ≤ 1.5 × ULN f. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome 8. Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption. 9. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. In women of childbearing potential, urine or serum pregnancy test must be negative within 28 days prior to registration. In postmenopausal women or hysterectomized patients, pregnancy tests do not need to be performed Exclusion Criteria: 1. Ineligible for appropriate locoregional treatment (breast surgery and or radiotherapy when indicated) 2. Bilateral invasive breast cancer or synchronous DCIS in contralateral breast 3. Patients receiving concurrent systemic exogenous sexual hormone therapy during the study (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil, etc.) are not eligible but topical vaginal estrogen therapy is allowable. 4. Any chronic medication contraindicated for antineoplastic treatment 5. Participation in a prior or concurrent interventional study and receiving study treatment (concurrent or within 30 days prior to treatment start) 6) Patients receiving any prior systemic cancer therapy for invasive breast cancer 7\) Patients with a history of any malignancy are ineligible except for the following circumstances: * Patients with a malignancy history other than adequately treated invasive breast cancer are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at very low risk for recurrence of that malignancy (e.g. stage I gastric cancer or skin cancer) * Patients with the following cancers are eligible, even if diagnosed and adequately treated within the past 2 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic nonmelanomatous skin cancers 8) Patient has medical or psychiatric disorders that would, in the investigator's judgement, interfere with the patient's safety or informed consent (e.g. known uncontrolled HIV infection, chronic/active viral or other known hepatitis and/or chronic liver disease, cirrhosis etc.). 9\) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation 10) Patient has current impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral study treatments (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection) 11) Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator´s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol or limit life expectancy to ≤5 years 12) Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during study treatment and 6 months thereafter

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)

FacilityCityRegionStatus
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

Official registry record

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