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| Name | Class |
|---|---|
| Russian Society of Clinical Oncology | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with HR+/HER2- ABC/MBC who received abemaciclib based therapy for their ABC/MBC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time To Chemotherapy (TTC) | TTC is defined as the time from date of start of treatment to the date of the first documented chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically confirmed HR-positive, HER2-negative breast cancer treated with abemaciclib in combination with endocrine therapy or as a single agent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian Society of Clinical Oncology | Moscow | 127051 | Russia |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
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|
| Abemaciclib | 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 | Drug | Abemaciclib 200 mg orally every 12 hours |
|
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| 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 | Up to 5 years |
| Frequency of AE/SAE | occurenec of AE/SAE during therapy | Up to 5 years |