Clinical trial NCT06705504: A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib
Official title: Real-world Effectiveness and Safety in HR+/HER2- Advanced or Metastatic BC Patients Treated With Ribociclib or Alpelisib: A European Non-interventional Retrospective Study (REASSURE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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 malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data.


Eligibility criteria: Inclusion criteria:

* Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physician took the decision to initiate treatment with ribociclib or alpelisib.
* Patients with at least one prescription for ribociclib or alpelisib during the index period (01 January 2018 to 30 September 2021).

Exclusion criteria:

* Patients who were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and other); patients who were participating in other investigator-initiated research or non-interventional study (NIS) could be included as long as their standard of care was not altered by the study.
* Patients on active treatment for malignancies other than HR+/HER2- aBC/mBC at the time of index.
* IPO-Porto cohort only:

  * Patients who had participated or were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and others).
  * Patients who underwent part of the treatment for locally advanced/metastatic not amenable to surgery HR+/HER2- BC outside the center.

Primary outcomes:
measure: Real-world Progression-free Survival (rwPFS)
timeFrame: Up to 51 months
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Number of Patients by Age Group
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Number of Patients Categorized by Year of Index Date
timeFrame: Baseline
measure: Number of Patients With a History of Breast Cancer
timeFrame: Baseline
measure: Number of Patients by Comorbidity
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Number of Patients per BMI Category
timeFrame: Baseline
measure: Number of Patients by Menopausal Status
timeFrame: Baseline
measure: Number of patients per Charlson Comorbidity Index (CCI) Score Category
timeFrame: Baseline
measure: Number of Patients Categorized by Duration of Disease Recurrence
timeFrame: Baseline
measure: Number of Patients by Smoking Status
timeFrame: Baseline
measure: Number of Patients Categorized by Primary Tumor Type
timeFrame: Baseline
measure: Number of Patients Categorized by Disease Site
timeFrame: Baseline
measure: Number of Patients With Primary Metastatic Disease
timeFrame: Baseline
measure: Number of Patients Categorized by Number of Metastatic Sites
timeFrame: Baseline
measure: Number of Patients Categorized by Type of Metastases
timeFrame: Baseline
measure: Number of Patients Categorized by Time From Diagnosis to Metastasis
timeFrame: Baseline
measure: Number of Patients With Asymptomatic Disease
timeFrame: Baseline
measure: Number of Patients Categorized by Tumor Grade
timeFrame: Baseline
measure: Number of Patients Categorized by Stage of Cancer
timeFrame: Baseline
measure: Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Score
timeFrame: Baseline
measure: Number of Patients Categorized by Previous Types of Treatment
timeFrame: Baseline
measure: Number of Patients Categorized by the Number of Prior Lines of Endocrine Therapy (ET)
timeFrame: Baseline
measure: Number of Patients Resistant to ET
timeFrame: Baseline
measure: Number of Patients Sensitive to Hormonal Therapy
timeFrame: Baseline
measure: Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment Received
timeFrame: Baseline
measure: Number of Patients Categorized by the Number of Previous Lines of Treatment
timeFrame: Baseline
measure: Baseline Neutrophil-to-lymphocyte Ratio (NLr)
timeFrame: Baseline
measure: Baseline Platelet-to-lymphocyte Ratio (PLr)
timeFrame: Baseline
measure: Baseline Lymphocytes-to-monocytes Ratio (LMr)
timeFrame: Baseline
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: