A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib

Registration Number
NCT06705504
Lead Sponsor
Novartis
Brief Summary

This study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with ribociclib or alpelisib between the period of 01 January 2018 and 30 September 2021. Patients who were receiving active treatment for m...

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
435
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Real-world Progression-free Survival (rwPFS)Up to 51 months

rwPFS was defined as the time from the index date to the date of the first documented progression or death due to any cause. If a patient did not have an event, rwPFS was censored at the date of the last adequate tumor assessment. The index date was defined as the date of the first treatment with ribociclib or alpelisib.

Secondary Outcome Measures
NameTimeMethod
Number of Patients Categorized by Stage of CancerBaseline

Cancer Stages: I, IIA, IIB, IIIA, IIIB, IIIC, and IV.

AgeBaseline
Number of Patients by Age GroupBaseline

Age groups:

* Younger than 65 years

* 65 years or older

GenderBaseline
Number of Patients Categorized by Year of Index DateBaseline

The index date was defined as the date of the first treatment with ribociclib or alpelisib.

Number of Patients With a History of Breast CancerBaseline
Number of Patients by ComorbidityBaseline

Comorbidities included:

* Diabetes mellitus

* Cardiovascular disease

* Cerebrovascular disease

* Chronic obstructive pulmonary disease (COPD)

* Dementia

* Depression

* Heart Failure

* Hypertension

* Hypothyroidism

* Ischemic heart disease

* Liver disease

* Myocardial infarction

* Osteoporosis

* Peripheral vascular disease

* Renal Disease
...

Body Mass Index (BMI)Baseline
Number of Patients per BMI CategoryBaseline

BMI Categories:

* Underweight: below 18.5 kilograms per meter squared (kg/m\^2)

* Healthy/normal weight: 18.5 to 24.9 kg/m\^2

* Pre-obesity: 25 to 29.9 kg/m\^2

* Obesity: 30 kg/m\^2 and higher

Number of Patients by Menopausal StatusBaseline

Menopausal status:

* Pre- or peri-menopausal

* Post-menopausal

Number of patients per Charlson Comorbidity Index (CCI) Score CategoryBaseline

CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).

Number of Patients Categorized by Duration of Disease RecurrenceBaseline

Disease recurrence categories:

* 12 months or less

* More than 12 months

Number of Patients by Smoking StatusBaseline

Smoking status:

* Current smoker

* Former smoker

* Never smoked

Number of Patients Categorized by Primary Tumor TypeBaseline

Tumor types:

* Invasive ductal

* Lobular carcinoma

* Other

Number of Patients Categorized by Disease SiteBaseline

Disease site categories:

* Non-visceral

* Visceral

* Multiple

Number of Patients With Primary Metastatic DiseaseBaseline
Number of Patients Categorized by Number of Metastatic SitesBaseline

Categories for number of metastatic sites: 0, 1, 2, 3, 4 or more.

Number of Patients Categorized by Type of MetastasesBaseline

Metastases:

* Local/breast metastases

* Bone metastases

* Lung metastases

* Liver metastases

* Central nervous system metastases

* Lymph node metastases

* Other metastases

Number of Patients Categorized by Time From Diagnosis to MetastasisBaseline

Categories:

* 24 months or less

* More than 24 months

* Metastatic BC at diagnosis

Number of Patients With Asymptomatic DiseaseBaseline
Number of Patients Categorized by Tumor GradeBaseline

Tumor Grades:

* Grade 1

* Grade 2

* Grade 3

Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance ScoreBaseline

ECOG performance score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores ranged from a lower value of 0 (fully active, able to carry out all pre-disease performance without restriction) up to 4 (completely disabled; cannot carry out any selfcare; to...

Number of Patients Categorized by Previous Types of TreatmentBaseline

Treatment categories:

* Chemotherapy

* Surgery

* Radiotherapy

* Adjuvant endocrine therapy

* Everolimus treatment

Number of Patients Categorized by the Number of Prior Lines of Endocrine Therapy (ET)Baseline

Categories for number of lines of ET: 0, 1, 2, and 3 or more.

Number of Patients Resistant to ETBaseline
Number of Patients Sensitive to Hormonal TherapyBaseline
Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment ReceivedBaseline

CDK4/6i lines of treatment:

* Adjuvant

* 1st metastatic line

* 2nd metastatic line

* 3rd metastatic line or later

Number of Patients Categorized by the Number of Previous Lines of TreatmentBaseline

Categories for number of lines of treatment: 0, 1, 2, and 3 or more.

Baseline Neutrophil-to-lymphocyte Ratio (NLr)Baseline
Baseline Platelet-to-lymphocyte Ratio (PLr)Baseline
Baseline Lymphocytes-to-monocytes Ratio (LMr)Baseline

Trial Locations

Locations (1)

Novartis

🇺🇸

East Hanover, New Jersey, United States

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