A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06830720
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • ribociclib + AI ± LHRH — DRUG
    ribociclib in combination with an aromatase inhibitor ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
  • abemaciclib + ET ± LHRH — DRUG
    abemaciclib in combination with an endocrine therapy ± LHRH as described in the current effective summary of product characteristics. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.
  • ET mono ± LHRH — DRUG
    endocrine monotherapy ± LHRH. This is an observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Study Details

This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.

Key Dates

Start date
Feb 20, 2025
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
3,250 participants (estimated)

Arms

  • Arm: ribociclib
    ribociclib + AI ± LHRH
  • Arm: abemaciclib
    abemaciclib + ET ± LHRH
  • Arm: ET mono
    ET mono ± LHRH

Primary Outcome Measure

Invasive disease-free survival (iDFS) for adjuvant therapy with ribociclib + AI ± LHRH in participants with HR+/HER2- eBC at high risk of recurrence [ Time Frame: 36 months ]

Central Contacts

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