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Abemaciclib in Combination With Endocrine Therapy as First Line Therapy in Metastatic Breast Cancer Patients

NCT04681768 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2025-09-26

No results posted yet for this study

Summary

Breast cancer is one of the most common cancers in women. 20-30 % of all breast cancer patients are faced with advanced disease, comprising both locally advanced breast cancer (LABC) and metastatic breast cancer (MBC). 80% of MBC cases are diagnosed as hormone receptor (HR) positive disease. The main systemic treatment options for these women include endocrine therapy (ET). The need of over-coming de novo or acquired resistance to ET in metastatic breast cancer has led to the integration of CDK4/6 inhibitors into combined ET of MBC. Abemaciclib represents a selective and potent small molecule inhibitor of CDK4/6 which has been granted approval by the European Medical Association (EMA). In two phase III trials Abemaciclib has been shown to double treatment efficacy in terms of PFS prolongation, to improve ORR and to prolong overall survival. At the same time, it has been shown that side effects of the drug are well manageable and QoL of patients under Abemaciclib is maintained.

Conditions

  • Breast Cancer/ Metastatic Breast Cancer

Interventions

DRUG

Abemaciclib

Abemaciclib tablets 150 mg, 100 mg, 50 mg as clinical routine: 150 mg twice daily per os, in-label administration in combination with endocrine therapy (aromatase inhibitor or Fulvestrant)

Sponsors & Collaborators

Principal Investigators

  • Johannes Ettl, MD · Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Frauenheilkunde

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2025-01-20
Completion
2025-04-01

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT04681768 on ClinicalTrials.gov