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

NCT ID: NCT05789771

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Abemaciclib

Intervention Type: DRUG

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)

Abemaciclib

Intervention Type: DRUG

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)

Abemaciclib

Intervention Type: DRUG

Abemaciclib 200 mg orally every 12 hours

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Abemaciclib

Abemaciclib 200 mg orally every 12 hours

Intervention Type: DRUG

Other Intervention Names

VERZENIO; VERZENIO; VERZENIO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Society of Clinical Oncology

UNKNOWN

Sponsor Role: collaborator

Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Russian Society of Clinical Oncology

Moscow, , Russia

Countries

Russia

Other Identifiers

15.03.2023

Identifier Type: -

Identifier Source: org_study_id