NoLEEta - Phase III non-inferiority trial of chemotherapy de-escalation in hormone receptor positive, Her2-negative, intermediate-risk early breast cancer treated with Ribociclib (LEE-011) in the adjuvant setting.
Introduction
The study investigates whether adjuvant treatment with ribociclib allows adjuvant chemotherapy to be omitted in patients with HR+ HER2- early breast cancer and an intermediate risk of recurrence.
The target population in this study are patients with ER+ HER2- breast cancer and the following risk constellations: pT0-2 pN1, pT3-4 pN0, pT2 pN0 G3, or pT2 pN0 G2 with Ki67 ≥20%. They must have undergone curative surgery and be suitable for chemotherapy. Patients must not have been previously treated with a CDK4/6 inhibitor or chemotherapy. The indication for chemotherapy can be made either on the basis of clinical-pathological parameters (decision by the investigator in accordance with guidelines) or using a genomic signature.
After curative surgery, randomization into two study arms takes place:
- Arm A (study arm): Ribociclib in combination with endocrine therapy
- Arm B (control arm): Chemotherapy followed by ribociclib and endocrine therapy
News
Patient recruitment has begun globally. In Germany, the first patients were enrolled in June.
Design
Further information on the study
The sponsor of the study is Unicancer.
EUCT-number: 2025-520979-13-00
Protocol Code of the Sponsor: UC-BCG-2501
Contact
Dr. Christin Wünsche
