HR+/HER2- Breast CancerATLANTNCT05789771
Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.
An observational study of HR+/HER2- Breast Cancer and Metastatic Disease, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+/HER2- Breast Cancer, Metastatic Disease, Аdvanced Disease
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 136 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Being tested
- Abemaciclib
- Keywords
- HR+/HER2- breast cancer, abemaciclib
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called VERZENIO
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)
AbemaciclibDrug
Also called VERZENIO
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)
AbemaciclibDrug
Also called VERZENIO
Abemaciclib 200 mg orally every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC. | Not described Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 5 years
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: Up to 5 years
Frequency of AE/SAE
occurenec of AE/SAE during therapy
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Russian Society of Clinical Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789771
- Sponsor's protocol ID
- 15.03.2023
- Acronym
- ATLANT
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05789771
- Acronym / sponsor ID
- ATLANT / 15.03.2023
- Keywords
- HR+/HER2- breast cancer, abemaciclib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Collaborators
- Russian Society of Clinical Oncology
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC. | – | Drug: Abemaciclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibAlso: VERZENIOAbemaciclib 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 | patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC. |
| AbemaciclibAlso: VERZENIOAbemaciclib 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 | patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC. |
| AbemaciclibAlso: VERZENIOAbemaciclib 200 mg orally every 12 hours | Drug | patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC. |
Primary outcome
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
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 5 years
Time To Chemotherapy (TTC)
Time frame: Up to 5 years
Time To New Treatment Options (TTN)
Time frame: Up to 5 years
Frequency of AE/SAE
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HR+/HER2- Breast Cancer and Metastatic Disease, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) of patients receiving abemaciclib (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.