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NCT04565054 · ClinicalTrials.gov record · last posted 2025-11-19

Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC

Study acronym: ADAPTlate
StatusActive, Not Recruiting
PhasePhase 3
Started2020-09-02
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from the ClinicalTrials.gov record
Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study. This patient group is currently offered a standard of care chemotherapy plus endocrine therapy (ET). The study investigates whether the patient group with high-risk early breast cancer benefits from treatment with the medication abemaciclib in combination with ET compared to ET alone.

Protocol amendment history 1 change detected by DataLookout

2026-08-09
notable
Sponsor changed: West German Study Group → Women's Cancer Study Group GmbH
WasWest German Study Group
NowWomen's Cancer Study Group GmbH
Trial Details
NCT Number NCT04565054
Lead Sponsor West German Study Group
Collaborators: Eli Lilly and Company, Genomic Health®, Inc.
Conditions Breast Cancer Female
Enrollment 1,260 participants
Start Date 2020-09-02
Primary Completion 2028-06 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2025-11-19