NCT05789771

Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.

Abemaciclib Combined With Endocrine Therapy or as a Single Agent for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia. Prospective, Multicentre, Non-interventional, Observational Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 136 (actual)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ATLANT study is prospective, multicentre, non-interventional, observational study. Patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.

Detailed description

The ATLANT study is prospective, multicentre, non-interventional, observational study. 136 patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy in different line therapy. The purpose of this study is to better understand how abemciclib combinations are used in real-life conditions and their clinical impact for the treatment of Russian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).

Conditions

• HR+/HER2- Breast Cancer
• Metastatic Disease
• Аdvanced Disease

Interventions

Type	Name	Description
DRUG	Abemaciclib	Abemaciclib 150 mg orally every 12 hours plus Aromatase Inhibitor ( Anastrozole 1 mg, Letrozole 2.5 mg or exemestane 25 mg orally every 24 hours on Days 1 to 28 of a 28-day cycle)
DRUG	Abemaciclib	Abemaciclib 150 mg orally every 12 hours plus Fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on Day 1 of a 28-day cycle)
DRUG	Abemaciclib	Abemaciclib 200 mg orally every 12 hours

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2023-03-29
• Last updated: 2023-03-31

Locations

1 site across 1 country: Russia

Regulatory

• FDA-regulated drug study