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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
Scientific title
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)
Secondary ID [1] 0 0
2022-503001-38-00
Secondary ID [2] 0 0
CLEE011O12001
Universal Trial Number (UTN)
Trial acronym
Adjuvant WIDER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years
Timepoint [1] 0 0
At 3 years
Secondary outcome [1] 0 0
Incidence and severity of adverse events (AEs) using CTCAE v4.03
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Invasive Disease-Free Survival (iDFS)
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
Distant Disease-Free Survival (DDFS)
Timepoint [3] 0 0
Up to approximately 6 years
Secondary outcome [4] 0 0
Distant Relapse-Free Survival (DRFS)
Timepoint [4] 0 0
Up to approximately 6 years
Secondary outcome [5] 0 0
Recurrence-Free Interval (RFI)
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
Relative dose intensity (RDI) of ribociclib
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Up to approximately 6 years
Secondary outcome [8] 0 0
Time To Discontinuation (TTD) of ribociclib
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
Timepoint [10] 0 0
Up to approximately 6 years
Secondary outcome [11] 0 0
Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
Timepoint [11] 0 0
Up to approximately 6 years
Secondary outcome [12] 0 0
Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
Timepoint [12] 0 0
Up to approximately 6 years
Secondary outcome [13] 0 0
Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
Timepoint [13] 0 0
Up to approximately 6 years

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 (BC).
* 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 participants should have at least 3 years remaining of endocrine adjuvant therapy.
* 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.
* 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 inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
20/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/09/2030
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gateshead
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
Israel
State/province [2] 0 0
Tel Aviv
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Incheon
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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