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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05827081
Registration number
NCT05827081
Ethics application status
Date submitted
12/04/2023
Date registered
24/04/2023
Titles & IDs
Public title
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
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Scientific title
A Phase IIIb Study to Characterize the Effectiveness and Safety of Adjuvant Ribociclib in a Wide Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)
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Secondary ID [1]
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CLEE011O12001
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Universal Trial Number (UTN)
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Trial acronym
Adjuvant WIDER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ribociclib
Treatment: Drugs - Letrozole
Treatment: Drugs - Ansastrozole
Treatment: Drugs - Goserelin
Treatment: Drugs - Leuprolide
Treatment: Drugs - Exemestane
Experimental: Ribociclib + endocrine therapy - 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)
Treatment: Drugs: Ribociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Treatment: Drugs: Letrozole
Letrozole 2.5 mg orally once daily continuously
Treatment: Drugs: Ansastrozole
Anastrozole 1 mg orally once daily continuously.
Treatment: Drugs: 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
Treatment: Drugs: 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
Treatment: Drugs: Exemestane
Exemestane 25 mg once daily continuously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years
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Assessment method [1]
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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.
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Timepoint [1]
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At 3 years
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Secondary outcome [1]
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Invasive Disease-Free Survival (iDFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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Distant Relapse-Free Survival (DRFS)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 6 years
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Secondary outcome [3]
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Recurrence-Free Interval (RFI)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 6 years
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Secondary outcome [4]
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Relative dose intensity (RDI) of ribociclib
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Assessment method [4]
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RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is defined as time from the start of study treatment to date of death due to any cause.
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Timepoint [5]
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Up to approximately 6 years
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Secondary outcome [6]
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Time To Discontinuation (TTD) of ribociclib
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Assessment method [6]
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TTD is defined as the time from starting ribociclib to the time to treatment discontinuation due to any cause.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
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Assessment method [7]
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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.
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Timepoint [7]
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Up to approximately 6 years
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Secondary outcome [8]
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Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
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Assessment method [8]
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The FACT-ES is a questionnaire that consists of 19 items which assesses endocrine complaints and adverse events.
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Timepoint [8]
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Up to approximately 6 years
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Secondary outcome [9]
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Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
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Assessment method [9]
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The FACIT-F is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
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Timepoint [9]
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Up to approximately 6 years
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Secondary outcome [10]
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Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
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Assessment method [10]
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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.
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Timepoint [10]
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Up to approximately 6 years
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Secondary outcome [11]
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Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
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Assessment method [11]
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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.
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Timepoint [11]
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Up to approximately 6 years
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Eligibility
Key inclusion criteria
Key
* Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
* Participant has HER2-negative breast cancer
* 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 the participant should have at least 3 years remaining of endocrine adjuvant therapy. For participants with prior ET treatment > 12 months, the investigator should rule out disease recurrence prior to enrollment. The number of participants with prior ET between 12 and 36 months will be capped at 1000.
* Participant has no contraindication for the adjuvant ET in the study.
* Participant after complete surgical resection with the final surgical specimen microscopic margins free from tumor and in one of below categories:
* Anatomic Stage Group III
* Anatomic Stage Group II (subset)
* Anatomic Stage Group I (high-risk subset as exploratory cohort)
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2.
* Participant has adequate bone marrow and organ function.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
* Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET.
* Participant has any other concurrent severe and/or uncontrolled medical condition
* 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.
Other inlcusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Suspended
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
20/09/2030
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Actual
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Sample size
Target
3100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Gateshead
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Recruitment postcode(s) [1]
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2290 - Gateshead
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
An open-label, multicenter, phase IIIb, single-arm study to evaluate the safety and efficacy of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a wide patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, II (subset) or I (high-risk subset as exploratory cohort) early Breast Cancer (EBC)
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Trial website
https://clinicaltrials.gov/study/NCT05827081
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05827081