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Breast CancerCATTALYSTNCT07710716

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

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
How many people
3,000 participants
Where
1 siteSwitzerland
Study dates
9 Apr 2026to 30 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients diagnosed with HR+/HER2- eBC who have undergone surgical resection of the primary breast tumor and initiated adjuvant ET.

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Novartis

    Basel, 4056

Other trials in Switzerland

About this study

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

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.

Conditions
Breast Cancer
Keywords
Early Breast Cancer, HR+/HER2-
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT07710716
Study groupRoleWhat they receive
Cohort A: Contemporaneous Ribociclib-eligible PatientsAdult HR+/HER2- eBC patients who have undergone surgical resection of the primary breast tumor and initiated adjuvant ET and meet additional staging criteria including either Stage III, or Stage IIB, or Stage IIA with N1, Stage IIA with N0 and Grade 3, or Stage IIA with N0 and Grade 2 and Ki-67 ≥20% or high genomic risk.
Cohort B: Ribociclib-treated PatientsAdult HR+/HER2- eBC patients who have undergone surgical resection of the primary breast tumor and initiated adjuvant ribociclib in addition to ET.
Subcohort B1: Ribociclib-treated Subcohort for Landmark Safety AnalysisPatients in Cohort B who have at least six months of potential follow-up time after ribociclib initiation at the time of the analysis.

What is being measured

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

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

    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)

    Measured: Baseline

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

    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

    Measured: Baseline

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

    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).

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

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

    Measured: Baseline

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: 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

    Measured: Up to 40 months

Secondary outcomes (45)

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

    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)

    Measured: Baseline

  2. Cohort A: CCI

    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).

    Measured: Baseline

  3. Cohort A: Duration Between Initial Diagnosis and Surgery

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

  8. Cohort A: Duration of ET by Type

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 40 months

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Up to 40 months

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

    Measured: Baseline

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    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.

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    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).

    Measured: Up to 40 months

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

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

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

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

    Measured: Up to 40 months

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

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

  39. Cohort A: Proportion of Patients With Potential DDIs

    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.

    Measured: Up to 58 months

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

    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.

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

    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)

    Measured: Up to 40 months

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

    Measured: Up to 40 months

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

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

    Measured: Up to 40 months

Timeline

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

  1. First posted17 Jul 2026
  2. Study start9 Apr 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

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
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07710716
Sponsor's protocol ID
CLEE011O12006
Acronym
CATTALYST
Status last verified
Oct 2026
First submitted
13 Jul 2026
Last updated
13 Oct 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.

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 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. 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 Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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?

Cohort B and Subcohort B1: Proportion of Patients by Baseline Demographics and Clinical Characteristics (time frame: Baseline). The study lists 17 primary outcomes in all. 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 NCT07710716.

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 13 Oct 2026.

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