NCT05827081|RecruitingPhase 3FDA Drug

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Adjuvant WIDER

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)

Novartis Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

CLEE011O120012022-503001-38-00

Study Type

interventional

Target

1,400

Locations

16 countries

Sites

205

Timeline

RegisteredApr 2023

StartedFeb 2024

CompletionSep 2030

Brief Summary

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,400

participants targeted

Target at P75+ for phase_3

Timeline

53mo left

Started Feb 2024

Longer than P75 for phase_3

Geographic Reach

16 countries

205 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.6 years study duration

Study Progress33%

Feb 2024Sep 2030

First Submitted

Initial submission to the registry

April 12, 2023

Completed

12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed

10 months until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed

5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2029

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.5 years

First QC Date

April 12, 2023

Last Update Submit

April 30, 2026

Conditions

Early Breast Cancer

Keywords

Hormone receptor positive (HR+)Human epidermal growth factor receptor-2 negative (HER2-)Early breast cancer (EBC)premenopausalpostmenopausalmale breast cancerribociclibLEE011Endocrine therapy (ET)

Outcome Measures

Primary Outcomes (1)

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years
iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. The iBCFS rate at 3 years will be assessed.
At 3 years

Secondary Outcomes (13)

Incidence and severity of adverse events (AEs) using CTCAE v4.03
Up to approximately 6 years
Invasive Disease-Free Survival (iDFS)
Up to approximately 6 years
Distant Disease-Free Survival (DDFS)
Up to approximately 6 years
Distant Relapse-Free Survival (DRFS)
Up to approximately 6 years
Recurrence-Free Interval (RFI)
Up to approximately 6 years
+8 more secondary outcomes

Study Arms (1)

Ribociclib + endocrine therapy

EXPERIMENTAL

Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of: * For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously. * For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin subcutaneously (at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used) or leuprolide subcutaneously (at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used)

Drug: RibociclibDrug: LetrozoleDrug: AnsastrozoleDrug: GoserelinDrug: LeuprolideDrug: Exemestane