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New treatment option for Early and Locally Advanced Breast Cancer
Official title ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
ClinicalTrials.gov ID: NCT07084558
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Signed informed consent obtained prior to any study specific assessments and procedures
- Women and men of age ≥18 years
- 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...
You likely can't join if
- Ineligible for appropriate locoregional treatment (breast surgery and or radiotherapy when indicated)
- Bilateral invasive breast cancer or synchronous DCIS in contralateral breast
- Patients receiving concurrent systemic exogenous sexual hormone therapy during the study (hormone replacement therapy, oral or any other hormonal...
- Any chronic medication contraindicated for antineoplastic treatment
- Participation in a prior or concurrent treatment study and receiving study treatment (concurrent or within 30 days prior to treatment start) 6)...
- Patients with a malignancy history other than adequately treated invasive breast cancer are eligible if they have been disease-free for at least 2...
See the full eligibility criteria
Who can join
- Signed informed consent obtained prior to any study specific assessments and procedures
- Women and men of age ≥18 years
- 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...
- ER positive tumors, i.e. \>20% positive stained tumor cells
- PR positive or negative tumors
- Systemic chemotherapy indicated by multidisciplinary tumor board
- Absence of prior breast cancer specific treatment for the current malignancy when entering screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow and organ function as defined by the following local laboratory values within 8 weeks before study treatment start:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 10.0 g/dL
- Serum creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m² for patients with serum creatinine levels above institutional ULN.
- 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...
- Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.
- Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- 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
What rules you out
- Ineligible for appropriate locoregional treatment (breast surgery and or radiotherapy when indicated)
- Bilateral invasive breast cancer or synchronous DCIS in contralateral breast
- 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...
- Any chronic medication contraindicated for antineoplastic treatment
- Participation in a prior or concurrent treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria, Austria
- Baden, Austria
- Dornbirn, Austria
- Feldkirch, Austria
- Graz, Austria
- Innsbruck, Austria
- Linz, Austria
- Salzburg, Austria
- Sankt Pölten, Austria
- Sankt Veit an der Glan, Austria
- Vienna, Austria
- Wiener Neustadt, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria, Austria; Baden, Austria; Dornbirn, Austria; Feldkirch, Austria; Graz, Austria; Innsbruck, Austria and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.