A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib
- Conditions
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of Patients Categorized by Stage of Cancer Baseline Cancer Stages: I, IIA, IIB, IIIA, IIIB, IIIC, and IV.
Age Baseline Number of Patients by Age Group Baseline Age groups:
* Younger than 65 years
* 65 years or olderGender Baseline Number of Patients Categorized by Year of Index Date Baseline The index date was defined as the date of the first treatment with ribociclib or alpelisib.
Number of Patients With a History of Breast Cancer Baseline Number of Patients by Comorbidity Baseline 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 Category Baseline 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 higherNumber of Patients by Menopausal Status Baseline Menopausal status:
* Pre- or peri-menopausal
* Post-menopausalNumber of patients per Charlson Comorbidity Index (CCI) Score Category Baseline 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 Recurrence Baseline Disease recurrence categories:
* 12 months or less
* More than 12 monthsNumber of Patients by Smoking Status Baseline Smoking status:
* Current smoker
* Former smoker
* Never smokedNumber of Patients Categorized by Primary Tumor Type Baseline Tumor types:
* Invasive ductal
* Lobular carcinoma
* OtherNumber of Patients Categorized by Disease Site Baseline Disease site categories:
* Non-visceral
* Visceral
* MultipleNumber of Patients With Primary Metastatic Disease Baseline Number of Patients Categorized by Number of Metastatic Sites Baseline Categories for number of metastatic sites: 0, 1, 2, 3, 4 or more.
Number of Patients Categorized by Type of Metastases Baseline Metastases:
* Local/breast metastases
* Bone metastases
* Lung metastases
* Liver metastases
* Central nervous system metastases
* Lymph node metastases
* Other metastasesNumber of Patients Categorized by Time From Diagnosis to Metastasis Baseline Categories:
* 24 months or less
* More than 24 months
* Metastatic BC at diagnosisNumber of Patients With Asymptomatic Disease Baseline Number of Patients Categorized by Tumor Grade Baseline Tumor Grades:
* Grade 1
* Grade 2
* Grade 3Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Score Baseline 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 Treatment Baseline Treatment categories:
* Chemotherapy
* Surgery
* Radiotherapy
* Adjuvant endocrine therapy
* Everolimus treatmentNumber 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 ET Baseline Number of Patients Sensitive to Hormonal Therapy Baseline Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment Received Baseline CDK4/6i lines of treatment:
* Adjuvant
* 1st metastatic line
* 2nd metastatic line
* 3rd metastatic line or laterNumber of Patients Categorized by the Number of Previous Lines of Treatment Baseline 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