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

NCT05789771 | Completed DMC FDA Drug

• 1 other identifier: 15.03.2023
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HR+/HER2- breast cancer; abemaciclib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Response Rate (ORR)

  Up to 5 years

• Time To Chemotherapy (TTC)

  Up to 5 years

• Time To New Treatment Options (TTN)

  Up to 5 years

• Frequency of AE/SAE

  Up to 5 years

Study Arms (1)

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

Drug: Abemaciclib

Interventions

Abemaciclib 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)

Also known as: VERZENIO

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histologically confirmed HR-positive, HER2-negative breast cancer treated with abemaciclib in combination with endocrine therapy or as a single agent

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead
• Russian Society of Clinical Oncology: collaborator

Study Sites (1)

Russian Society of Clinical Oncology

Moscow, 127051, Russia

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

RU (1)