An observational study in Hormone Receptor Positive HER-2 Negative Breast Cancer, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Novartis · Observational
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 malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 435 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study.
Exclusion criteria:
IPO-Porto cohort only:
Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's oncology evidence network (OEN), ICO, and initiated treatment with ribociclib or alpelisib.
Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, Curie, and initiated treatment with ribociclib or alpelisib.
Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, IPO-Porto, and initiated treatment with ribociclib or alpelisib.
Patients with HR+/HER2- advanced or metastatic BC who were registered in Czech Republic local sites or clinics proposed by Novartis affiliates and initiated treatment with ribociclib or alpelisib.
Real-world Progression-free Survival (rwPFS)
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.
Time frame: Up to 51 months
Age
Time frame: Baseline
Number of Patients by Age Group
Age groups: * Younger than 65 years * 65 years or older
Time frame: Baseline
Gender
Time frame: Baseline
Number of Patients Categorized by Year of Index Date
The index date was defined as the date of the first treatment with ribociclib or alpelisib.
Time frame: Baseline
Number of Patients With a History of Breast Cancer
Time frame: Baseline
Number of Patients by Comorbidity
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 * Rheumatological disease * Ulcer disease * Other
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Number of Patients per BMI Category
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
Time frame: Baseline
Number of Patients by Menopausal Status
Menopausal status: * Pre- or peri-menopausal * Post-menopausal
Time frame: Baseline
Number of patients per Charlson Comorbidity Index (CCI) Score Category
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).
Time frame: Baseline
Number of Patients Categorized by Duration of Disease Recurrence
Disease recurrence categories: * 12 months or less * More than 12 months
Time frame: Baseline
Number of Patients by Smoking Status
Smoking status: * Current smoker * Former smoker * Never smoked
Time frame: Baseline
Number of Patients Categorized by Primary Tumor Type
Tumor types: * Invasive ductal * Lobular carcinoma * Other
Time frame: Baseline
Number of Patients Categorized by Disease Site
Disease site categories: * Non-visceral * Visceral * Multiple
Time frame: Baseline
Number of Patients With Primary Metastatic Disease
Time frame: Baseline
Number of Patients Categorized by Number of Metastatic Sites
Categories for number of metastatic sites: 0, 1, 2, 3, 4 or more.
Time frame: Baseline
Number of Patients Categorized by Type of Metastases
Metastases: * Local/breast metastases * Bone metastases * Lung metastases * Liver metastases * Central nervous system metastases * Lymph node metastases * Other metastases
Time frame: Baseline
Number of Patients Categorized by Time From Diagnosis to Metastasis
Categories: * 24 months or less * More than 24 months * Metastatic BC at diagnosis
Time frame: Baseline
Number of Patients With Asymptomatic Disease
Time frame: Baseline
Number of Patients Categorized by Tumor Grade
Tumor Grades: * Grade 1 * Grade 2 * Grade 3
Time frame: Baseline
Number of Patients Categorized by Stage of Cancer
Cancer Stages: I, IIA, IIB, IIIA, IIIB, IIIC, and IV.
Time frame: Baseline
Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Score
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; totally confined to bed or chair).
Time frame: Baseline
Number of Patients Categorized by Previous Types of Treatment
Treatment categories: * Chemotherapy * Surgery * Radiotherapy * Adjuvant endocrine therapy * Everolimus treatment
Time frame: Baseline
Number of Patients Categorized by the Number of Prior Lines of Endocrine Therapy (ET)
Categories for number of lines of ET: 0, 1, 2, and 3 or more.
Time frame: Baseline
Number of Patients Resistant to ET
Time frame: Baseline
Number of Patients Sensitive to Hormonal Therapy
Time frame: Baseline
Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment Received
CDK4/6i lines of treatment: * Adjuvant * 1st metastatic line * 2nd metastatic line * 3rd metastatic line or later
Time frame: Baseline
Number of Patients Categorized by the Number of Previous Lines of Treatment
Categories for number of lines of treatment: 0, 1, 2, and 3 or more.
Time frame: Baseline
Baseline Neutrophil-to-lymphocyte Ratio (NLr)
Time frame: Baseline
Baseline Platelet-to-lymphocyte Ratio (PLr)
Time frame: Baseline
Baseline Lymphocytes-to-monocytes Ratio (LMr)
Time frame: Baseline
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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