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Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.

NCT ID: NCT07243002

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-15

Study Completion Date

2030-05-30

Brief Summary

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This non-interventional study (NIS) aims to evaluate effectiveness, persistence, treatment patterns, adverse events (AEs), and patient-reported experience (including adherence, treatment satisfaction, health-related quality of life \[HRQoL\], work productivity, and etc.), among HR+/HER2- stage II and III eBC patients treated with ribociclib + ET, and to evaluate AEs and patients-reported experience among HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET, as per local label.

Detailed Description

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This will be a multi-center, multi-country, observational, non-interventional, hybrid study among HR+/HER2- stage II or III eBC patients treated with ribociclib + ET or abemaciclib + ET, as per local label in routine clinical care settings.

The study will include a retrospective and a prospective part. The hybrid design will combine retrospective data extraction from patients' EHRs and prospective data collection from validated PRO questionnaires, bespoke questions, and qualitative interviews, to provide comprehensive data on the patient population.

The exploratory objectives will assess HR+/HER2- stage II and III eBC patients treated with abemaciclib + ET. No formal comparison between the cohorts will be made

Conditions

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Breast Cancer

Keywords

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ribociclib, abemacicblib Breast Cancer Non interventional study

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Ribociclib arm

Patient treated with ribociclib and Endocrine Therapy (ET) per standard of care

No interventions assigned to this group

Abemaciclib arm

Patient treated with abemaciclib and Endocrine Therapy (ET) per standard of care

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Males or females.
* Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx).
* Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis.
* Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria.
* Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment).
* Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date:

* Tested positive for estrogen receptor (ER+), or
* Tested positive for progesterone receptor (PR+), or
* Tested positive for both.
* Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date.

Exclusion Criteria

* Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date.
* Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period.
* Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CLEE011O12005

Identifier Type: -

Identifier Source: org_study_id