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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Ribociclib

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01317 000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population was composed only of women aged 18 years or older.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Ribociclib; Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLEE011ABR02 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: first-line treatment; HR+/HER2-,; advanced breast cancer,; ribociclib,; non-steroidal aromatase inhibitors,
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011ABR02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No