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

November 22, 2024 updated by: Novartis

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
435

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Institut de Cancérologie de l'Ouest (ICO) Cohort
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.
L'Institut Curie (Curie) Cohort
Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, Curie, and initiated treatment with ribociclib or alpelisib.
Instituto Português de Oncologia do Porto (IPO-Porto) Cohort
Patients with HR+/HER2- advanced or metastatic BC who were registered in IQVIA's OEN, IPO-Porto, and initiated treatment with ribociclib or alpelisib.
Czech Republic Cohort
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Real-world Progression-free Survival (rwPFS)
Time Frame: 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.
Up to 51 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Baseline
Baseline
Age
Time Frame: Baseline
Baseline
Body Mass Index (BMI)
Time Frame: Baseline
Baseline
Number of Patients by Age Group
Time Frame: Baseline

Age groups:

  • Younger than 65 years
  • 65 years or older
Baseline
Number of Patients Categorized by Year of Index Date
Time Frame: Baseline
The index date was defined as the date of the first treatment with ribociclib or alpelisib.
Baseline
Number of Patients With a History of Breast Cancer
Time Frame: Baseline
Baseline
Number of Patients by Comorbidity
Time Frame: 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
  • Rheumatological disease
  • Ulcer disease
  • Other
Baseline
Number of Patients per BMI Category
Time Frame: 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 higher
Baseline
Number of Patients by Menopausal Status
Time Frame: Baseline

Menopausal status:

  • Pre- or peri-menopausal
  • Post-menopausal
Baseline
Number of patients per Charlson Comorbidity Index (CCI) Score Category
Time Frame: 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).
Baseline
Number of Patients Categorized by Duration of Disease Recurrence
Time Frame: Baseline

Disease recurrence categories:

  • 12 months or less
  • More than 12 months
Baseline
Number of Patients by Smoking Status
Time Frame: Baseline

Smoking status:

  • Current smoker
  • Former smoker
  • Never smoked
Baseline
Number of Patients Categorized by Primary Tumor Type
Time Frame: Baseline

Tumor types:

  • Invasive ductal
  • Lobular carcinoma
  • Other
Baseline
Number of Patients Categorized by Disease Site
Time Frame: Baseline

Disease site categories:

  • Non-visceral
  • Visceral
  • Multiple
Baseline
Number of Patients With Primary Metastatic Disease
Time Frame: Baseline
Baseline
Number of Patients Categorized by Number of Metastatic Sites
Time Frame: Baseline
Categories for number of metastatic sites: 0, 1, 2, 3, 4 or more.
Baseline
Number of Patients Categorized by Type of Metastases
Time Frame: Baseline

Metastases:

  • Local/breast metastases
  • Bone metastases
  • Lung metastases
  • Liver metastases
  • Central nervous system metastases
  • Lymph node metastases
  • Other metastases
Baseline
Number of Patients Categorized by Time From Diagnosis to Metastasis
Time Frame: Baseline

Categories:

  • 24 months or less
  • More than 24 months
  • Metastatic BC at diagnosis
Baseline
Number of Patients With Asymptomatic Disease
Time Frame: Baseline
Baseline
Number of Patients Categorized by Tumor Grade
Time Frame: Baseline

Tumor Grades:

  • Grade 1
  • Grade 2
  • Grade 3
Baseline
Number of Patients Categorized by Stage of Cancer
Time Frame: Baseline
Cancer Stages: I, IIA, IIB, IIIA, IIIB, IIIC, and IV.
Baseline
Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Score
Time Frame: 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; totally confined to bed or chair).
Baseline
Number of Patients Categorized by Previous Types of Treatment
Time Frame: Baseline

Treatment categories:

  • Chemotherapy
  • Surgery
  • Radiotherapy
  • Adjuvant endocrine therapy
  • Everolimus treatment
Baseline
Number of Patients Categorized by the Number of Prior Lines of Endocrine Therapy (ET)
Time Frame: Baseline
Categories for number of lines of ET: 0, 1, 2, and 3 or more.
Baseline
Number of Patients Resistant to ET
Time Frame: Baseline
Baseline
Number of Patients Sensitive to Hormonal Therapy
Time Frame: Baseline
Baseline
Number of Patients Categorized by Line of Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment Received
Time Frame: Baseline

CDK4/6i lines of treatment:

  • Adjuvant
  • 1st metastatic line
  • 2nd metastatic line
  • 3rd metastatic line or later
Baseline
Number of Patients Categorized by the Number of Previous Lines of Treatment
Time Frame: Baseline
Categories for number of lines of treatment: 0, 1, 2, and 3 or more.
Baseline
Baseline Neutrophil-to-lymphocyte Ratio (NLr)
Time Frame: Baseline
Baseline
Baseline Platelet-to-lymphocyte Ratio (PLr)
Time Frame: Baseline
Baseline
Baseline Lymphocytes-to-monocytes Ratio (LMr)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLEE011A3002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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