A phase IIIb study to characterize the efficacy and safety of Adjuvant ribociclib plus endocrine therapy in a close-to-clinical practice patient population with HR+ HER2− early breast cancer (Adjuvant WIDER)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503001-38-01

Acronym

CLEE011O12001

Enrollment

172

Registered

2025-06-11

Start date

2025-07-08

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HR-positive HER-2- negative Breast Cancer

Brief summary

iBCFS using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials), as assessed by Investigator

Detailed description

Incidence and severity of adverse events (AEs) using CTCAE v4.03, iDFS utilisant les critères STEEP version 2.0, DRFS using STEEP Version 2.0 criteria, RFI using STEEP Version 2.0 criteria, Relative Dose Intensity (RDI), Overall survival (OS) defined as from the start of treatment to date of death due to any cause., Time to discontinuation (TTD) of ribociclib, Changes from Baseline in FACT-B, FACT-ES, FACIT-F, EQ-5D-5L and WPAI-GH PRO questionnaires, DDFS using STEEP Version 2.0 criteria

Interventions

DRUGGOSERELIN

DRUGEXEMESTANE

DRUGANASTROZOLE

DRUGLETROZOLE

DRUGLEUPRORELIN ACETATE

DRUGRIBOCICLIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
iBCFS using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials), as assessed by Investigator	—

Secondary

Measure	Time frame
Incidence and severity of adverse events (AEs) using CTCAE v4.03, iDFS utilisant les critères STEEP version 2.0, DRFS using STEEP Version 2.0 criteria, RFI using STEEP Version 2.0 criteria, Relative Dose Intensity (RDI), Overall survival (OS) defined as from the start of treatment to date of death due to any cause., Time to discontinuation (TTD) of ribociclib, Changes from Baseline in FACT-B, FACT-ES, FACIT-F, EQ-5D-5L and WPAI-GH PRO questionnaires, DDFS using STEEP Version 2.0 criteria	—

Measure

Time frame

—

Countries

Germany, Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026