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

Metastatic Disease Clinical Trial

— ATLANT  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789771
• Other study ID #: 15.03.2023
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2023
• Source: Blokhin's Russian Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. ?atients 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Disease
• Neoplasm Metastasis

Intervention

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)
• 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)
• Abemaciclib
Abemaciclib 200 mg orally every 12 hours

Locations

Country	Name	City	State
Russian Federation	Russian Society of Clinical Oncology	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center	Russian Society of Clinical Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Frequency of AE/SAE	occurenec of AE/SAE during therapy	Up to 5 years