A real-world study on how well ribociclib and hormone therapy work together to prevent early breast cancer from coming back.

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 positive HER2 negative early breast cancer (Adjuvant WIDER) - Adjuvant WIDER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092443

Enrollment

3100

Registered

2025-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: ribociclib: 400 mg once daily in a 3 weeks on or 1 week off in combination with endocrine therapy for 36 months Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: Approximately 2800 participants will have breast cancer that is stage III, stage IIB or IIA meeting certain criteria, and approximately 300 participants will have high risk Stage I breast cancer. To qualify to join the study, participants must have at least 3 years remaining of standard hormone therapy, which is the duration of treatment on study.

Exclusion criteria

Exclusion criteria: Participants cannot be on any other anti-cancer therapy, be pregnant or breast feeding, or plan to become pregnant during the trial. Participants must not have any uncontrolled medical condition, including heart conditions.

Design outcomes

Primary

Measure	Time frame
The main question this trial is designed to answer is if early breast cancer participants receiving ribociclib in combination with hormonal therapy have the cancer coming back after 3 years using STEEP (Standardized Definition for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials) by InvestigatorsTimepoint: Your Study Doctor will assess if there are any signs of tumor growth in the breast tissue or other parts of the body.	—

Measure

Time frame

The main question this trial is designed to answer is if early breast cancer participants receiving ribociclib in combination with hormonal therapy have the cancer coming back after 3 years using STEEP (Standardized Definition for Efficacy Endpoints in Adjuvant Breast Cancer Clinical Trials) by InvestigatorsTimepoint: Your Study Doctor will assess if there are any signs of tumor growth in the breast tissue or other parts of the body.

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Secondary

Measure	Time frame
If ribociclib plus hormonal therapy is safe Timepoint: Number and severity of side effects (adverse events) until 30 days after the end of treatment ;If and when participants cancer comes back including breast and or new cancerTimepoint: Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months and every 6 cycles thereafter until confirmation of distant recurrence ;If and when participants breast cancer spreads to other parts of the bodyTimepoint: Within 4 weeks after clinical suspicion of recurrence;How long does it take from start of treatment until the return of participants breast cancer if applicableTimepoint: Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months and every 6 cycles thereafter until confirmation of distant recurrence;How concentrated the ribociclib dose wasTimepoint: Once daily on days 1 to 21 of each 28-day cycle for 39 cycles from C1D1 ;If and when participants stop taking ribociclibTimepoint: Continuous up to 30 days after last dose of study treatment;How many participants are still alive from the start to the end of the study.Timepoint: Rate at which participants die until end of the study;How participants feel and manage daily life when taking ribociclib plus hormonal therapy and after until their cancer returns or until end of the studyTimepoint: Every 3 cycles from C1D1 during the first 24 months every 6 cycles thereafter until 12 months after confirmation of distant recurrence At EoT and every recurrence unless within 4 weeks of last PRO assessment	—

Measure

Time frame

If ribociclib plus hormonal therapy is safe Timepoint: Number and severity of side effects (adverse events) until 30 days after the end of treatment ;If and when participants cancer comes back including breast and or new cancerTimepoint: Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months and every 6 cycles thereafter until confirmation of distant recurrence ;If and when participants breast cancer spreads to other parts of the bodyTimepoint: Within 4 weeks after clinical suspicion of recurrence;How long does it take from start of treatment until the return of participants breast cancer if applicableTimepoint: Every 3 cycles starting from Cycle 1 Day 1 during the first 24 months and every 6 cycles thereafter until confirmation of distant recurrence;How concentrated the ribociclib dose wasTimepoint: Once daily on days 1 to 21 of each 28-day cycle for 39 cycles from C1D1 ;If and when participants stop taking ribociclibTimepoint: Continuous up to 30 days after last dose of study treatment;How many participants are still alive from the start to the end of the study.Timepoint: Rate at which participants die until end of the study;How participants feel and manage daily life when taking ribociclib plus hormonal therapy and after until their cancer returns or until end of the studyTimepoint: Every 3 cycles from C1D1 during the first 24 months every 6 cycles thereafter until 12 months after confirmation of distant recurrence At EoT and every recurrence unless within 4 weeks of last PRO assessment

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Countries

Argentina, Australia, Brazil, Canada, France, Germany, Hong Kong, India, Israel, Italy, Mexico, Portugal, Republic of Korea, Spain, Taiwan, Turkey, United Kingdom, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com912250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026