ABCSG 66 / ADAPTela Study Details
ABCSG 66 / ADAPTela is a WSG-sponsored, adjuvant, open-label, interventional Phase III clinical trial for a high-risk HR-positive/HER2-negative early breast cancer patient population, comparing elacestrant with standard of care endocrine treatment (both arms with or without ribociclib). The genomic Oncotype DX® test is used to determine a specific genomic profile of patients, making it a personalized therapeutic approach to predict treatment benefits in HR-positive/HER2-negative early breast cancer.
| Study Start: | Q2/2026 |
| Coordinating Investigator: | Dr. Christoph Suppan (für AT) |
| Sample size: | 1520 (Germany, Spain and Austria) |
| Studien design: (Click to enlarge) |
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| Sponsor | WSG |
Treatment:
1. Arm A: Elacestrant (+/- CDK4/6-Inhibitor Ribociclib)
2. Arm B: SOC ET (+/- CDK4/6-Inhibitor)
Primary Objective(s)
To show efficacy in terms of improved survival (iDFS) in patients receiving adjuvant elacestrant-containing therapy (+/- CDK4/6i) compared to SoC ET (+/- CDK4/6i) only
Secondary Objectives
- Survival Objectives:
To assess distant disease-free survival (dDFS), relapse-free survival
(RFS), DCIS disease-free survival (DFS-DCIS), invasive breast cancer-free survival (IBCFS), locoregional relapse-free survival (LRFS), and OS - Safety Objectives:
To assess toxicity in both arms - Translational Objectives:
To assess predictive markers (translational research) at baseline and in on treatment blood samples and/or core biopsies at different timepoints.
Patient Population:
HR-positive/HER2-negative early-stage breast cancer patients with an intermediate to high risk of recurrence.
At the time of study enrollment, patients must have completed standard-of-care (SoC) primary treatment (including, for example, endocrine induction therapy, (neo)adjuvant chemotherapy, surgery, and radiotherapy) and are now expected to start endocrine therapy with or without a CDK4/6 inhibitor. If endocrine therapy (with or without a CDK4/6 inhibitor) has already been initiated, enrollment is also permitted within 12 months of starting treatment.
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