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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569187
• Other study ID #: CLEE011ABR02
• Status: Completed
• Start date: March 23, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Ribociclib
Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results for CLEE011ABR02 from the Novartis Clinical Trials Website