NCT05827081ClinicalTrials.gov

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 31400 partecipanti ricercati229 centri16 paesi

Categorie

Oncologia75%Dermatologia14%Endocrino e metabolico11%

Registrato in 1 registro

ClinicalTrials.govNCT05827081Apri questa scheda su ClinicalTrials.govSincronizzato l’altro ieri

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-04-24; recorded start 2024-02-28
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1128 other studies in this databaseCounted from the lead sponsor named in the record (Novartis Pharmaceuticals)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 229 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,400 participants (target), run at 229 sites, across 16 countries.

How this score is built

Enrolment31/40
1,400 participants (target)
Site count25/25
229 sites
Country count15/15
16 countries
Planned duration10/10
Planned over about 80 months
Sponsor scale10/10
Novartis Pharmaceuticals has led 1,104 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

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).

The study consists of Screening, Treatment, and Follow-up periods. * Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment. * Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study \[EOS\]), whichever occurs first.

Patologie

Early Breast Cancer

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – 100 Years
Volontari sani	No

Idoneità come riportata nel registro

Key Inclusion criteria: * Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC). * Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment. * Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample. * Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy. * For participants with prior ET treatment \> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment. * The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants. * Participant has no contraindication to receive adjuvant ET in the study. * Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: * Anatomic Stage Group III, or * Anatomic Stage Group IIB, or * A subset of Anatomic Stage Group IIA. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2. * Participant has adequate bone marrow and organ function. * ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as: * QTcF interval at Screening \< 450 msec (QT interval using Fridericia's correction). * Mean resting heart rate 50-99 beats per minute (determined from the ECG). Key Exclusion criteria: * Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery. * Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET. * Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years. * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality. * Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial. * Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment. Other inclusion/exclusion criteria may apply

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Non applicabile
Modello di intervento	SINGLE_GROUP
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	1400 partecipanti ricercati

Sponsor e collaboratori

Novartis Pharmaceuticals Sponsor

Bracci e interventi

Ribociclib + endocrine therapyEXPERIMENTAL
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)

Interventi

Farmaco Ansastrozole
Anastrozole 1 mg orally once daily continuously.
Farmaco Exemestane
Exemestane 25 mg once daily continuously
Farmaco Goserelin
Goserelin administered 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
Farmaco Letrozole
Letrozole 2.5 mg orally once daily continuously
Farmaco Leuprolide
Leuprolide administered 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
Farmaco Ribociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest

Esiti misurati

Esito primario
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.
Orizzonte temporale At 3 years
Esito secondario
Incidence and severity of adverse events (AEs) using CTCAE v4.03
To evaluate Safety of ribociclib + ET
Orizzonte temporale Up to approximately 6 years
Esito secondario
Invasive Disease-Free Survival (iDFS)
iDFS is defined as the time from the date of first dose of study treatment to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed using STEEP 2.0 as assessed by the investigator.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Distant Disease-Free Survival (DDFS)
Distant Disease-Free Survival (DDFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site, death (any cause), or second primary non-breast invasive cancer (excluding in situ/non-invasive cancers and basal and squamous cell carcinomas of the skin). DDFS will be assessed using STEEP 2.0 as assessed by the investigator.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Distant Relapse-Free Survival (DRFS)
Distant Relapse Free Survival (DRFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site or death (any cause). DRFS will be assessed using STEEP 2.0 as assessed by the investigator.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Recurrence-Free Interval (RFI)
RFI is defined as the time from date of first dose to date of first event of invasive recurrence in the ipsilateral breast or locoregionally, at a distant site, or death from breast cancer. RFI will be assessed using STEEP 2.0 as per investigator assessment.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Relative dose intensity (RDI) of ribociclib
RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.
Orizzonte temporale Up to 3 years
Esito secondario
Overall Survival (OS)
OS is defined as time from the start of study treatment to date of death due to any cause.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Time To Discontinuation (TTD) of ribociclib
TTD is defined as the time from starting ribociclib to the time to treatment discontinuation due to any cause.
Orizzonte temporale Up to 3 years
Esito secondario
Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
The FACT-ES is a questionnaire that consists of 19 items which assesses endocrine complaints and adverse events.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
The FACIT-F is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D-5L health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Orizzonte temporale Up to approximately 6 years
Esito secondario
Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
WPAI-GH measures the impact of health problems on the participant's productivity, in paid or unpaid activities, in the last 7 days. It is 6-item scale measuring absenteeism, presenteeism, and impairments in unpaid activity.
Orizzonte temporale Up to approximately 6 years

Date

Date
Data di inizio	28 febbraio 2024 (effettiva)
Conclusione primaria	7 settembre 2029 (stimata)
Conclusione	20 settembre 2030 (stimata)
Prima pubblicazione	24 aprile 2023 (effettiva)
Ultimo aggiornamento	18 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

118 centri stanno reclutando

Argentina

Argentina
Struttura	Città	Stato o regione	Stato
Novartis Investigative Site	Caba	Buenos Aires	Attivo, non in reclutamento
Novartis Investigative Site	Córdoba		In reclutamento
Novartis Investigative Site	La Plata	Buenos Aires	In reclutamento

Australia

Australia
Struttura	Città	Stato o regione	Stato
Novartis Investigative Site	Clayton	Victoria	Attivo, non in reclutamento
Novartis Investigative Site	East Melbourne	Victoria	Attivo, non in reclutamento
Novartis Investigative Site	Gateshead	New South Wales	Attivo, non in reclutamento
Novartis Investigative Site	Tiwi	Northern Territory	Attivo, non in reclutamento

Brazil

Brazil
Struttura	Città	Stato o regione	Stato
Novartis Investigative Site	Belo Horizonte	Minas Gerais	In reclutamento
Novartis Investigative Site	Porto Alegre	Rio Grande do Sul	In reclutamento
Novartis Investigative Site	Porto Alegre	Rio Grande do Sul	In reclutamento
Novartis Investigative Site	Porto Alegre	Rio Grande do Sul	In reclutamento
Novartis Investigative Site	Rio de Janeiro		In reclutamento
Novartis Investigative Site	Rio de Janeiro		In reclutamento
Novartis Investigative Site	Salvador	Estado de Bahia	In reclutamento
Novartis Investigative Site	São Paulo	São Paulo	In reclutamento
Novartis Investigative Site	São Paulo	São Paulo	In reclutamento
Novartis Investigative Site	São Paulo		In reclutamento

Canada

Canada
Struttura	Città	Stato o regione	Stato
Novartis Investigative Site	Halifax	Nova Scotia	Attivo, non in reclutamento
Novartis Investigative Site	Montreal	Quebec	In reclutamento
Novartis Investigative Site	Montreal	Quebec	In reclutamento
Novartis Investigative Site	Montreal	Quebec	Attivo, non in reclutamento
Novartis Investigative Site	Oakville	Ontario	Attivo, non in reclutamento
Novartis Investigative Site	Ottawa	Ontario	Attivo, non in reclutamento
Novartis Investigative Site	Québec	Quebec	In reclutamento
Novartis Investigative Site	Saskatoon	Saskatchewan	Attivo, non in reclutamento
Novartis Investigative Site	Toronto	Ontario	In reclutamento
Novartis Investigative Site	Toronto	Ontario	In reclutamento
Novartis Investigative Site	Victoria	British Columbia	Attivo, non in reclutamento

China

China
Struttura	Città	Stato o regione	Stato
Novartis Investigative Site	Beijing		Attivo, non in reclutamento
Novartis Investigative Site	Beijing	Beijing Municipality	Attivo, non in reclutamento
Novartis Investigative Site	Beijing		Attivo, non in reclutamento
Novartis Investigative Site	Changchun	Jilin	Attivo, non in reclutamento
Novartis Investigative Site	Chengdu	Sichuan	Attivo, non in reclutamento
Novartis Investigative Site	Chengdu	Sichuan	Attivo, non in reclutamento
Novartis Investigative Site	Guangzhou	Guangdong	Attivo, non in reclutamento
Novartis Investigative Site	Guangzhou		In reclutamento
Novartis Investigative Site	Hangzhou	Zhejiang	Attivo, non in reclutamento
Novartis Investigative Site	Hangzhou	Zhejiang	Attivo, non in reclutamento
Novartis Investigative Site	Harbin	Heilongjiang	In reclutamento
Novartis Investigative Site	Jinan	Shandong	Attivo, non in reclutamento
Novartis Investigative Site	Jinan	Shandong	Attivo, non in reclutamento
Novartis Investigative Site	Jining	Shandong	Attivo, non in reclutamento
Novartis Investigative Site	Nanchang	Jiangxi	Attivo, non in reclutamento
Novartis Investigative Site	Nanjing	Jiangsu	In reclutamento
Novartis Investigative Site	Qingdao		Attivo, non in reclutamento
Novartis Investigative Site	Shanghai		Attivo, non in reclutamento
Novartis Investigative Site	Shijiazhuang		Attivo, non in reclutamento
Novartis Investigative Site	Tianjin		Attivo, non in reclutamento
Novartis Investigative Site	Wenzhou	Zhejiang	Attivo, non in reclutamento
Novartis Investigative Site	Zhengzhou	Henan	Attivo, non in reclutamento

Nella scheda del registro sono indicati altri 179 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

4 settembre 2026
Centro aggiunto
1 site added (229 total)
228229
18 agosto 2026
Centro rimosso
1 site removed (228 total)
229228

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05827081