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

Overview

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.

Full Title of Study: “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.”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: December 1, 2022

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).

Interventions

• 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

Arms, Groups and Cohorts

• patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC.

Clinical Trial Outcome Measures

Primary Measures

• Progression-free Survival (PFS) of patients receiving abemaciclib
  • Time Frame: Up to 5 years
  • 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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥18 years 2. 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) 3. 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. 4. Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not amenable to curative therapy. 5. WHO performance status of 0-2 6. The patient has adequate organ function 7. Any number of prior therapies (including none) is permitted 8. Рatients who will start Abemaciclib as a Single Agent or in combination with endocrine therapy Exclusion Criteria:

1. 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. 2. Participants must not be pregnant or breastfeeding

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Blokhin’s Russian Cancer Research Center
• Collaborator
  • Russian Society of Clinical Oncology
• Provider of Information About this Clinical Study
  • Sponsor