Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Résumé

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Invasive Breast Cancer Free Survival (iBCFS) rate 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.

   Délai At 3 years

2. Critère de jugement secondaire

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

   To evaluate Safety of ribociclib + ET

   Délai Up to approximately 6 years

3. Critère de jugement secondaire

   Invasive Disease-Free Survival (iDFS)

   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.

   Délai Up to approximately 6 years

4. Critère de jugement secondaire

   Distant Disease-Free Survival (DDFS)

   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.

   Délai Up to approximately 6 years

5. Critère de jugement secondaire

   Distant Relapse-Free Survival (DRFS)

   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.

   Délai Up to approximately 6 years

6. Critère de jugement secondaire

   Recurrence-Free Interval (RFI)

   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.

   Délai Up to approximately 6 years

7. Critère de jugement secondaire

   Relative dose intensity (RDI) of ribociclib

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

   Délai Up to 3 years

8. Critère de jugement secondaire

   Overall Survival (OS)

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

   Délai Up to approximately 6 years

9. Critère de jugement secondaire

   Time To Discontinuation (TTD) of ribociclib

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

   Délai Up to 3 years

10. Critère de jugement secondaire

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

    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.

    Délai Up to approximately 6 years

11. Critère de jugement secondaire

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

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

    Délai Up to approximately 6 years

12. Critère de jugement secondaire

    Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score

    The FACIT-F is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.

    Délai Up to approximately 6 years

13. Critère de jugement secondaire

    Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score

    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.

    Délai Up to approximately 6 years

14. Critère de jugement secondaire

    Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score

    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.

    Délai Up to approximately 6 years

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

118 sites sont en recrutement

179 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

1. 4 septembre 2026

   Site ajouté

   1 site added (229 total)

   228 → 229

2. 18 août 2026

   Site retiré

   1 site removed (228 total)

   229 → 228