Active — Not RecruitingNot Applicable

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

Switzerland3,000 participantsStarted 2026-04-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Trial details

NCT IDNCT07710716

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria