Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years

Time frame · 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.

Incidence and severity of adverse events (AEs) using CTCAE v4.03

Time frame · Up to approximately 6 years

To evaluate Safety of ribociclib + ET

Invasive Disease-Free Survival (iDFS)

Time frame · Up to approximately 6 years

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.

Distant Disease-Free Survival (DDFS)

Time frame · Up to approximately 6 years

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.

Distant Relapse-Free Survival (DRFS)

Time frame · Up to approximately 6 years

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.

Recurrence-Free Interval (RFI)

Time frame · Up to approximately 6 years

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.

Relative dose intensity (RDI) of ribociclib

Time frame · Up to 3 years

RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.

Overall Survival (OS)

Time frame · Up to approximately 6 years

OS is defined as time from the start of study treatment to date of death due to any cause.

Time To Discontinuation (TTD) of ribociclib

Time frame · Up to 3 years

TTD is defined as the time from starting ribociclib to the time to treatment discontinuation due to any cause.

Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score

Time frame · Up to approximately 6 years

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.

Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score

Time frame · Up to approximately 6 years

The FACT-ES is a questionnaire that consists of 19 items which assesses endocrine complaints and adverse events.