Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational, Retrospective, Multicenter, National Study of the Effectiveness of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in First-line Treatment of Brazilian Patients With HR+/HER2- Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Ribociclib


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Female patient ≥ 18 years of age. All the patients must have at least one year of follow-up Patients at an age not consistent with postmenopausal status could only participate if they had oophorectomy surgery or being on treatment with goserelin for ovarian suppression Post-menopausal women defined as age ≥ 60 years old or < 60 years old and amenorrhea for 12 months or more (in the absence of chemotherapy, tamoxifen, toremifene or goserelin use for ovarian suppression) Confirmed diagnosis of HR+/HER2- locally advanced or metastatic BC Never in use of CDK 4/6i Exclusion criteria Patients in menopause status other than postmenopausal (young patients must have undergone oophorectomy being on treatment with goserelin for ovarian suppression to be characterized as postmenopausal) Previous use, at any time, of CDK 4/6i The patient received any previous systemic therapy for advanced breast cancer Patients who have received (neo)adjuvant therapy for breast cancer are eligible. If previous (neo) adjuvant therapy has included letrozole or anastrozole, the disease- free interval should be longer than 12 months from completion of treatment until entry in this trial Patients who received ≤28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible Uncontrolled heart disease and/or clinically significant cardiac repolarization abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ribociclib in combination with non-steroidal aromatase inhibitors<br>Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year | Drug: Ribociclib<br>* Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HR+/HER2-,, advanced breast cancer,, ribociclib,, non-steroidal aromatase inhibitors,, first-line treatment