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Hormone Receptor Positive HER-2 Negative Breast CancerNCT06705504

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

An observational study of Hormone Receptor Positive HER-2 Negative Breast Cancer, run by Novartis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
435 participants
Where
1 siteUnited States
Study dates
11 Jun 2021to 30 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: This was a retrospective, noninterventional cohort study.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Novartis

    East Hanover, New Jersey, 07936

Other trials in United States

About this study

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)

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06705504
Study groupRoleWhat they receive
Institut de Cancérologie de l'Ouest (ICO) CohortPatients 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) CohortPatients 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) CohortPatients 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 CohortPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 51 months

Secondary outcomes (31)

  1. Age

    Measured: Baseline

  2. Number of Patients by Age Group

    Age groups:

    • Younger than 65 years
    • 65 years or older

    Measured: Baseline

  3. Gender

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. Number of Patients With a History of Breast Cancer

    Measured: Baseline

  6. 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

    Measured: Baseline

  7. Body Mass Index (BMI)

    Measured: Baseline

  8. 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

    Measured: Baseline

  9. Number of Patients by Menopausal Status

    Menopausal status:

    • Pre- or peri-menopausal
    • Post-menopausal

    Measured: Baseline

  10. 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).

    Measured: Baseline

  11. Number of Patients Categorized by Duration of Disease Recurrence

    Disease recurrence categories:

    • 12 months or less
    • More than 12 months

    Measured: Baseline

  12. Number of Patients by Smoking Status

    Smoking status:

    • Current smoker
    • Former smoker
    • Never smoked

    Measured: Baseline

  13. Number of Patients Categorized by Primary Tumor Type

    Tumor types:

    • Invasive ductal
    • Lobular carcinoma
    • Other

    Measured: Baseline

  14. Number of Patients Categorized by Disease Site

    Disease site categories:

    • Non-visceral
    • Visceral
    • Multiple

    Measured: Baseline

  15. Number of Patients With Primary Metastatic Disease

    Measured: Baseline

  16. Number of Patients Categorized by Number of Metastatic Sites

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

    Measured: Baseline

  17. 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

    Measured: Baseline

  18. Number of Patients Categorized by Time From Diagnosis to Metastasis

    Categories:

    • 24 months or less
    • More than 24 months
    • Metastatic BC at diagnosis

    Measured: Baseline

  19. Number of Patients With Asymptomatic Disease

    Measured: Baseline

  20. Number of Patients Categorized by Tumor Grade

    Tumor Grades:

    • Grade 1
    • Grade 2
    • Grade 3

    Measured: Baseline

  21. Number of Patients Categorized by Stage of Cancer

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

    Measured: Baseline

  22. 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).

    Measured: Baseline

  23. Number of Patients Categorized by Previous Types of Treatment

    Treatment categories:

    • Chemotherapy
    • Surgery
    • Radiotherapy
    • Adjuvant endocrine therapy
    • Everolimus treatment

    Measured: Baseline

  24. 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.

    Measured: Baseline

  25. Number of Patients Resistant to ET

    Measured: Baseline

  26. Number of Patients Sensitive to Hormonal Therapy

    Measured: Baseline

  27. 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

    Measured: Baseline

  28. 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.

    Measured: Baseline

  29. Baseline Neutrophil-to-lymphocyte Ratio (NLr)

    Measured: Baseline

  30. Baseline Platelet-to-lymphocyte Ratio (PLr)

    Measured: Baseline

  31. Baseline Lymphocytes-to-monocytes Ratio (LMr)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start11 Jun 2021
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705504
Sponsor's protocol ID
CLEE011A3002
Status last verified
Nov 2024
First submitted
22 Nov 2024
Last updated
26 Nov 2024
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hormone Receptor Positive HER-2 Negative Breast Cancer, run by Novartis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-world Progression-free Survival (rwPFS) (time frame: Up to 51 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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