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NCT Number: NCT07710716

A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients

The aim of this study is to assess the clinical adoption, treatment patterns, and safety of adjuvant ribociclib use in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) patients. This is a multi-country study using secondary real-world data sources.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Evidence of diagnosis of eBC during the identification period.
  • Aged ≥18 years at index diagnosis date. The index diagnosis date is the date of first diagnosis of eBC.
  • Anatomic stage I-III breast cancer (BC) per American Joint Committee on Cancer (AJCC), 8th Edition at index diagnosis date.
  • Evidence of HR+ during the study period:
  • have tested positive for estrogen receptor (ER+), or
  • have tested positive for progesterone receptor (PR+), or
  • have tested positive for both.
  • Tested negative for HER2 (HER2-) during the study period.
  • Evidence of surgical resection of the primary breast tumor at any time.
  • Received endocrine therapy (ET) in the adjuvant setting after index diagnosis date.

Exclusion criteria

  • Evidence of another secondary malignancy at any time prior to index diagnosis date.
  • Evidence of other primary cancer (except for skin cancer) at any time prior to index diagnosis date.
  • Patients who participate in an interventional clinical trial at any time prior to or during the study period.
  • Patients with severely incomplete or inconsistent data, precluding validity of results.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Primary outcomes

  1. Cohort B and Subcohort B1: Proportion of Patients by Baseline Demographics and Clinical Characteristics

    Time frame: Baseline

    Baseline characteristics (subject to data availability) include:

    • Age group
    • Sex
    • Race/Ethnicity
    • Geographic region
    • Insurance type
    • Menopausal status
    • Body mass index (BMI) category
    • Alcohol use
    • Year of initial BC diagnosis
    • Tumor stage and grade
    • Clinical pathological node and tumor stage
    • Multiple breast primary diagnoses (yes/no)
    • Eastern Cooperative Oncology Group (ECOG) performance status
    • Estrogen and progesterone receptor status
    • HER2 immunohistochemistry (IHC) test results (0, 1+, 2+, 3+)
    • HER2 Fluorescence In Situ Hybridization (FISH) test (positive, negative)
    • Ki-67 category (positive, negative)
    • Genomic risk score
    • Hepatic dysfunction (yes/no)
    • Renal dysfunction (yes/no)
    • Cardiovascular disease (yes/no)
    • Gastrointestinal (GI) dysfunction (yes/no)

  2. Cohort B and Subcohort B1: Proportion of Patients by Demographics and Clinical Characteristics at Index Treatment Date

    Time frame: Baseline

    The index treatment date is the date of adjuvant ribociclib treatment initiation. Demographics and clinical characteristics (subject to data availability) include:

    • Age group
    • Insurance type
    • Menopausal status
    • BMI category
    • ECOG performance status

  3. Cohort B and Subcohort B1: Charlson Comorbidity Index (CCI)

    Time frame: Baseline

    CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).

  4. Cohort B and Subcohort B1: AST Levels at Index Diagnosis Date and Index Treatment Date

    Time frame: Baseline

    Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.

  5. Cohort B and Subcohort B1: ALT Levels at Index Diagnosis Date and Index Treatment Date

    Time frame: Baseline

    Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.

  6. Cohort B and Subcohort B1: Total Bilirubin Level at Index Diagnosis Date and Index Treatment Date

    Time frame: Baseline

    Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.

  7. Cohort B and Subcohort B1: QTc Interval at Index Diagnosis Date and Index Treatment Date

    Time frame: Baseline

    Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.

  8. Cohort B and Subcohort B1: Neutrophil Count at Index Diagnosis Date and Index Treatment Date

    Time frame: Baseline

    Index diagnosis date is the date of first diagnosis of eBC. Index treatment date is the date of adjuvant ribociclib initiation.

  9. Cohort B and Subcohort B1: Duration Between Initial Diagnosis and Ribociclib Initiation

    Time frame: Up to 40 months

  10. Cohort B and Subcohort B1: Duration Between Initial Diagnosis and Surgery

    Time frame: Up to 40 months

  11. Cohort B and Subcohort B1: Duration Between Surgery and Ribociclib Initiation

    Time frame: Up to 40 months

  12. Cohort B and Subcohort B1: Proportion of Patients by Type of Surgery Prior to Ribociclib Initiation

    Time frame: Up to 40 months

  13. Cohort B and Subcohort B1: Proportion of Patients by Type of BC Treatment Prior to Ribociclib Initiation

    Time frame: Up to 40 months

  14. Cohort B and Subcohort B1: Duration of Neoadjuvant and Adjuvant Therapy by Type, Prior to Ribociclib Initiation

    Time frame: Up to 40 months

  15. Cohort B and Subcohort B1: Proportion of Patients by Year of ET Initiation, Prior to Ribociclib Initiation

    Time frame: Up to 40 months

  16. Cohort B and Subcohort B1: Duration of ET by Type, Prior to Ribociclib Initiation

    Time frame: Up to 40 months

  17. Cohort B and Subcohort B1: Duration of Other Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6i) Treatment by Type, Prior to Ribociclib Initiation

    Time frame: Up to 40 months

Secondary outcomes

  1. Cohort A: Proportion of Patients by Baseline Demographics and Clinical Characteristics

    Time frame: Baseline

    Baseline characteristics (subject to data availability) include:

    • Age group
    • Sex
    • Race/ethnicity
    • Geographic region
    • Insurance type
    • Menopausal status
    • BMI category
    • Alcohol use
    • Year of initial BC diagnosis
    • Tumor stage and grade
    • Clinical pathological node and tumor stage
    • Multiple breast primary diagnoses (yes/no)
    • ECOG performance status
    • Estrogen and progesterone receptor status
    • HER2 IHC test results (0, 1+, 2+, 3+)
    • HER2 FISH test (positive, negative)
    • Ki-67 category (positive, negative)
    • Genomic risk score
    • Hepatic dysfunction (yes/no)
    • Renal dysfunction (yes/no)
    • Cardiovascular disease (yes/no)
    • GI dysfunction (yes/no)

  2. Cohort A: CCI

    Time frame: Baseline

    CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be categorized as low (0-1) and high (≥2).

  3. Cohort A: Duration Between Initial Diagnosis and Surgery

    Time frame: Up to 58 months

  4. Cohort A: Proportion of Patients by Type of Surgery

    Time frame: Up to 58 months

  5. Cohort A: Proportion of Patients by Type of BC Treatment Received

    Time frame: Up to 58 months

  6. Cohort A: Duration of Neoadjuvant and Adjuvant Therapy by Type

    Time frame: Up to 58 months

  7. Cohort A: Proportion of Patients by Year of ET Initiation

    Time frame: Up to 58 months

  8. Cohort A: Duration of ET by Type

    Time frame: Up to 58 months

  9. Cohort A: Duration of Other CDK4/6i Treatment by Type

    Time frame: Up to 58 months

  10. Cohort A: Proportion of Patients by Type of Concomitant Medication Received

    Time frame: Up to 58 months

  11. Cohort B and Subcohort B1: Proportion of Patients Who Switch to an Alternative CDK4/6i

    Time frame: Up to 40 months

  12. Cohort B and Subcohort B1: Proportion of Patients Who Receive Concomitant Systemic and Local Oncology Therapies

    Time frame: Up to 40 months

  13. Cohort B and Subcohort B1: Proportion of Patients Who Receive Subsequent Systemic and Local Oncology Therapies Administered After Ribociclib Initiation

    Time frame: Up to 40 months

  14. Cohort B and Subcohort B1: Duration of Subsequent Systemic and Local Oncology Therapies Administered After Ribociclib Initiation, by Type of Therapy

    Time frame: Up to 40 months

  15. Cohort B and Subcohort B1: Time Between Discontinuation of Ribociclib and Start of Subsequent Systemic and Local Oncology Therapies, by Type of Therapy

    Time frame: Up to 40 months

  16. Cohort B and Subcohort B1: Initial Dose of Ribociclib

    Time frame: Baseline

  17. Cohort B and Subcohort B1: Proportion of Patients Who Undergo Ribociclib Dose Reduction

    Time frame: Up to 40 months

  18. Cohort B and Subcohort B1: Time to First Ribociclib Dose Reduction

    Time frame: Up to 40 months

  19. Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Dose Reduction

    Time frame: Up to 40 months

  20. Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Interruptions per Patient Prior to Ribociclib Dose Reduction

    Time frame: Up to 40 months

  21. Cohort B and Subcohort B1: Proportion of Patients Who Experience Ribociclib Dose Interruption

    Time frame: Up to 40 months

  22. Cohort B and Subcohort B1: Time to First Ribociclib Dose Interruption

    Time frame: Up to 40 months

  23. Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Dose Interruption

    Time frame: Up to 40 months

  24. Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Reductions per Patient Prior to Ribociclib Dose Interruption

    Time frame: Up to 40 months

  25. Cohort B and Subcohort B1: Proportion of Patients Who Discontinue Ribociclib Treatment

    Time frame: Up to 40 months

  26. Cohort B and Subcohort B1: Time-to-Discontinuation (TTD) of Ribociclib Treatment

    Time frame: Up to 40 months

  27. Cohort B and Subcohort B1: Proportion of Patients by Reason for Ribociclib Discontinuation

    Time frame: Up to 40 months

  28. Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Interruptions per Patient Prior to Ribociclib Discontinuation

    Time frame: Up to 40 months

  29. Cohort B and Subcohort B1: Number of Prior Ribociclib Dose Reductions per Patient Prior to Ribociclib Discontinuation

    Time frame: Up to 40 months

  30. Cohort B and Subcohort B1: Persistence of Ribociclib Treatment

    Time frame: Up to 40 months

    Persistence of ribociclib treatment, defined as the proportion of days covered (PDC) from the first prescription of ribociclib to data cut-off, discontinuation, or end of treatment.

  31. Cohort B and Subcohort B1: Number of Clinical Visits and/or Laboratory Assessments for Ribociclib Monitoring

    Time frame: Up to 40 months

  32. Cohort B and Subcohort B1: Cumulative Exposure to Ribociclib

    Time frame: Up to 40 months

    Cumulative exposure to ribociclib, measured as the dose of ribociclib multiplied by days received for each prescription during the treatment duration (original dose to discontinuation).

  33. Subcohort B1: Incidence of Adverse Events (AEs) of Interest

    Time frame: Up to 6 months

    AEs of interest include liver enzyme elevation, QT interval prolongation, neutropenia, fatigue, leukopenia, thrombocytopenia, anemia, infections, and interstitial lung disease/pneumonitis.

  34. Subcohort B1: Proportion of Patients Requiring Changes to the Ribociclib Regimen Following AE Occurrence

    Time frame: Up to 6 months

    Changes to ribociclib regimen include dose reduction, dose interruption, treatment discontinuation, switching to another CDK4/6i, and initiating supportive therapies.

  35. Subcohort B1: Proportion of Patients by the Sequalae of AEs

    Time frame: Up to 6 months

    Sequalae of AEs reported as follows: amelioration (improvement) of AE, progression of AE, resolution of AE, and recurrence of AE.

  36. Cohort B and Subcohort B1: Proportion of Patients Undergoing Drug-drug Interaction (DDI) Assessment Upon Ribociclib Initiation

    Time frame: Up to 40 months

  37. Cohort B and Subcohort B1: Proportion of Patients With Actual DDIs

    Time frame: Up to 40 months

    Actual DDIs will be defined based on clinical manifestation, assessed based on available data in each data set.

  38. Cohort B and Subcohort B1: Number of DDIs per Patient

    Time frame: Up to 40 months

  39. Cohort A: Proportion of Patients With Potential DDIs

    Time frame: Up to 58 months

    Potential DDIs will be defined as concomitant administration of ribociclib with another drug that can potentially alter the efficacy and safety of the interacting treatments.

  40. Cohort B and Subcohort B1: Proportion of Patients With Potential DDIs

    Time frame: Up to 40 months

    Potential DDIs will be defined as concomitant administration of ribociclib with another drug that can potentially alter the efficacy and safety of the interacting treatments.

  41. Cohort B and Subcohort B1: Proportion of Patients With Potential DDIs Who Experience AEs

    Time frame: Up to 40 months

  42. Cohort B and Subcohort B1: Proportion of Patients by Clinical Monitoring Practices Before and After DDI Occurrence

    Time frame: Up to 40 months

  43. Cohort B and Subcohort B1: Among Patients With Clinically Consequential DDIs, Number of Patients by Demographics and Clinical Characteristics

    Time frame: Up to 40 months

    Demographics and clinical characteristics include

    • Age group
    • Sex
    • Race/ethnicity
    • Geographic region
    • Insurance type
    • Menopausal status
    • BMI category
    • Alcohol use
    • Year of initial BC diagnosis
    • Tumor stage and grade
    • Clinical pathological node and tumor stage
    • Multiple breast primary diagnoses (yes/no)
    • ECOG performance status
    • Estrogen and progesterone receptor status
    • HER2 IHC test results (0, 1+, 2+, 3+)
    • HER2 FISH test (positive, negative)
    • Ki-67 category (positive, negative)
    • Genomic risk score
    • Hepatic dysfunction (yes/no)
    • Renal dysfunction (yes/no)
    • Cardiovascular disease (yes/no)
    • GI dysfunction (yes/no)

  44. Cohort B and Subcohort B1: Among Patients With Clinically Consequential DDIs, Number of Patients by BC Treatment Prior to Ribociclib

    Time frame: Up to 40 months

  45. Cohort B and Subcohort B1: Frequency of Ribociclib Treatment Modifications Related to DDIs

    Time frame: Up to 40 months

    Treatment modifications include dose adjustments, interruptions, reductions, discontinuations, and switches to other therapies.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in the Real-World Practice of HR+/HER2- Early Breast Cancer (CATTALYST)

Acronym: CATTALYST

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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