Clinical trial NCT05569187: Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: HR+/HER2-,
advanced breast cancer,
ribociclib,
non-steroidal aromatase inhibitors,
first-line treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was composed only of women aged 18 years or older.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients alive and progression-free from disease at 1 year
timeFrame: 1 year post-treatment
Secondary outcomes:
measure: Proportion of patients alive and progression-free from disease at 6 months
timeFrame: 6 months post-treatment
measure: Proportion of patients who had disease progression at 6 months
timeFrame: 6 months post-treatment
measure: Proportion of patients who had disease progression at 1 year
timeFrame: 1 year post-treatment
measure: Proportion of patients who died at 6 months
timeFrame: 6 months post-treatment
measure: Proportion of patients who died at 1 year
timeFrame: 1 year post-treatment
measure: Proportion and cause of patients who reduced a treatment dose at 6 months
timeFrame: 6 months post-treatment
measure: Proportion and cause of patients who reduced a treatment dose at 1 year
timeFrame: 1 year post-treatment
measure: Frequency of dose interruption and cause, per patient, at 1 year
timeFrame: 1 year post-treatment
measure: Adverse Event frequency and classification of the severity degree
timeFrame: throughout the study, approximately 1 year
measure: Pattern of the treatment of AE of interest at 6 months
timeFrame: 6 months post-treatment
measure: Pattern of the treatment of AE of interest at 12 months
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: