MedTrace Logo

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

NCT04565054 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2025-11-19

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cancer Female

Interventions

DRUG

Abemaciclib 50 MG; 150mg 1-0-1 per os

Experimental: Abemaciclib plus ET Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Genomic Health®, Inc.

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Oleg Gluz, PD Dr. med. · Westdeutsche Studiengruppe GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2028-06-30
Completion
2029-07-31

Countries

  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565054 on ClinicalTrials.gov