Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05827081




Registration number
NCT05827081
Ethics application status
Date submitted
12/04/2023
Date registered
24/04/2023
Date last updated
24/04/2024

Titles & IDs
Public title
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
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)
Secondary ID [1] 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
Invasive Disease-Free Survival (iDFS)
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Distant Relapse-Free Survival (DRFS)
Timepoint [2] 0 0
Up to approximately 6 years
Secondary outcome [3] 0 0
Recurrence-Free Interval (RFI)
Timepoint [3] 0 0
Up to approximately 6 years
Secondary outcome [4] 0 0
Relative dose intensity (RDI) of ribociclib
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 6 years
Secondary outcome [6] 0 0
Time To Discontinuation (TTD) of ribociclib
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
Timepoint [7] 0 0
Up to approximately 6 years
Secondary outcome [8] 0 0
Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
Timepoint [8] 0 0
Up to approximately 6 years
Secondary outcome [9] 0 0
Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
Timepoint [10] 0 0
Up to approximately 6 years
Secondary outcome [11] 0 0
Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
Timepoint [11] 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

- 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.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/09/2030
Actual
Sample size
Target
3100
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

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

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT05827081
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05827081