Clinical trial · Observational
Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.
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.
NCT05789771CI-TRIAL-00065211ATLANTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HR+/HER2- Breast Cancer | — | UNRESOLVED | — |
| Metastatic Disease | — | UNRESOLVED | — |
| Аdvanced Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC.
- interventionNames
- Drug: Abemaciclib
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) of patients receiving abemaciclib
- timeFrame
- Up to 5 years
- description
- 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 outcomes (4)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to 5 years
- description
- ORR is defined as the proportion of patients with best overall response of CR or PR according to RECIST 1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.