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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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HR+/HER2- Breast Cancer, Metastatic Disease, Аdvanced Disease

Intervention / Treatment
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* Drug: Abemaciclib
* Drug: Abemaciclib
* Drug: Abemaciclib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology/College of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC) Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not amenable to curative therapy. WHO performance status of 0-2 The patient has adequate organ function Any number of prior therapies (including none) is permitted Рatients who will start Abemaciclib as a Single Agent or in combination with endocrine therapy Exclusion Criteria: Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements. Participants must not be pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC.<br> | Drug: Abemaciclib<br>* 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)<br>* Other names: VERZENIO;Drug: Abemaciclib<br>* 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)<br>* Other names: VERZENIO;Drug: Abemaciclib<br>* Abemaciclib 200 mg orally every 12 hours<br>* Other names: VERZENIO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) of patients receiving abemaciclib | Progression-free Survival (PFS) of patients receiving abemaciclib in combination with endocrine therapy Progression-free Survival (PFS) of patients receiving abemaciclib as a single agent | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR is defined as the proportion of patients with best overall response of CR or PR according to RECIST 1.1. | Up to 5 years | 
| Time To Chemotherapy (TTC) | TTC is defined as the time from date of start of treatment to the date of the first documented chemotherapy | Up to 5 years | 
| Time To New Treatment Options (TTN) | TTN s defined as the time from date of start of treatment to the date of the first new New Treatment Options | Up to 5 years | 
| Frequency of AE/SAE | occurenec of AE/SAE during therapy | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HR+/HER2- breast cancer, abemaciclib