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Observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year.
The study was conducted in 11 Brazilian sites specialized in the treatment of this condition. The study data were collected from the review of medical records by the Investigator (or designated).
The sites must have had adequate medical records to ensure robust medical record review. Therefore, a feasibility assessment was carried out at potential site prior to the study implementation to assess the adequacy of medical records and the data routinely available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribociclib in combination with non-steroidal aromatase inhibitors | Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribociclib | Drug | Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients alive and progression-free from disease at 1 year | The purpose was to evaluate the effectiveness of first-line ribociclib in combination with non-steroidal aromatase inhibitors in a Brazilian female population diagnosed with HR+/HER2- locally advanced or metastatic BC. Effectiveness was measured by the proportion of patients alive and free of disease progression at 1 year. | 1 year post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients alive and progression-free from disease at 6 months | The purpose was to evaluate the effectiveness of first-line ribociclib in combination with non-steroidal aromatase inhibitors in a Brazilian female population diagnosed with HR+/HER2- locally advanced or metastatic BC. Effectiveness was measured by the proportion of patients alive and free of disease progression at 6 months post-treatment. |
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Inclusion criteria
Exclusion criteria
The study included women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors
The study population was composed only of women aged 18 years or older.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | São Paulo | São Paulo | 01317 000 | Brazil |
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| Label | URL |
|---|---|
| Results for CLEE011ABR02 from the Novartis Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000589651 | ribociclib |
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| 6 months post-treatment |
| Proportion of patients who had disease progression at 6 months | The purpose was to evaluate the proportion of patients who had disease progression at 6 months. | 6 months post-treatment |
| Proportion of patients who had disease progression at 1 year | The purpose was to evaluate the proportion of patients who had disease progression at 1 year. | 1 year post-treatment |
| Proportion of patients who died at 6 months | The purpose was to evaluate the proportion of patients who died at 6 months. | 6 months post-treatment |
| Proportion of patients who died at 1 year | The purpose was to evaluate the proportion of patients who died at 1 year. | 1 year post-treatment |
| Proportion and cause of patients who reduced a treatment dose at 6 months | Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg) | 6 months post-treatment |
| Proportion and cause of patients who reduced a treatment dose at 1 year | Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg) | 1 year post-treatment |
| Frequency of dose interruption and cause, per patient, at 1 year | The purpose was to evaluate frequency of dose interruption and cause, per patient, at 1 year. | 1 year post-treatment |
| Adverse Event frequency and classification of the severity degree | Frequency and classification of the degree of severity of the following adverse events of interest: neutropenia, febrile neutropenia, increased QT interval (> 60 ms,> 480ms ≤ 500 ms, and> 500 ms), AST/ALT elevation three times greater than upper limit. In relation to the adverse events of interest, they were classified regarding the severity, graded from 1 to 4, corresponding to mild, moderate, severe and life-threatening, or as described in the medical record. | throughout the study, approximately 1 year |
| Pattern of the treatment of AE of interest at 6 months | Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated. | 6 months post-treatment |
| Pattern of the treatment of AE of interest at 12 months | Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated. | 12 months post-treatment |
| D017437 |
| Skin and Connective Tissue Diseases |