Risk of recurrence in patients with N1 HR+/HER2- eBC

Indications:¹

• KISQALI^® (ribociclib), in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) at high risk of recurrence (see section 5.1 of the SmPC for eligibility criteria)

• In pre/perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist

KISQALI is not recommended to be used in combination with tamoxifen.

For information on the safety profile of KISQALI in eBC, click here.

Please consult the Summary of Product Characteristics for the full KISQALI safety and tolerability profile.

Stage II/III N1 patients may have a substantial recurrence risk regardless of disease characteristics²

In a recent real world analysis (US Flatiron database) of 45,236 patients who underwent primary breast cancer surgery and were treated with adjuvant ET^2*

This study is sponsored by Novartis Pharma AG

Early recurrence-free survival (RFS)^† differences between N1 cohorts showed converging long-term risk¹

Although recurrence events accumulated more rapidly in cohort A RFS was observed to be <70% in both groups at 10 years¹

RFS in N1 patients on ET alone

• Recurrences rise over time in both groups²
• Tumour size and grade influence recurrence timing²
  • Higher tumour burden (T≥5 cm) and histologic grade (G3) correlate with earlier recurrence²

*A retrospective, non-interventional real-world analysis of 45,236 stage II/III HR+/HER2– EBC patients >18 year old with N1 disease (including N1mi), who received adjuvant ET following surgical resection from the Flatiron Health Panoramic BC database. Initial diagnosis Jan 2011 Oct 2020; data cutoff Oct 2025. Median follow-up 9.3 years. Primary endpoints: RFS, DRFS and distant recurrence events at 5 and 10 years. Kaplan-Meier analysis was used to estimate survival curves and rates at 5 and 10 years. Epanechnikov kernel-smoothed annual hazards of recurrence were calculated to assess the risk of developing clinical outcome related events over time. Piecewise, multivariate Cox regression was used to analyse time-dependent changes in risk and estimate HR between Cohort A (N1 patients with Te≥5 cm or G3) and Cohort B (N1 patients with T<5 cm and G<3) in each year.²

^† RFS was defined as time from randomisation to locoregional or distant recurrence or death from any cause^1,2

AI, Aromatase inhibitor BC, breast cancer; CI: confidence interval; CDK4/6i: cyclin-dependent kinase 4/6 inhibitor; DRFS, distant recurrence-free survival; EBC, early breast cancer; ET, endocrine therapy; G, grade; HER2–: human epidermal growth factor receptor 2-negative; HR+, hormone receptor positive; HR, hazard ratio; HRER, high risk for early recurrence; HRLR, high risk for late recurrence mi: micrometastases; N1, metastases in 1–3 axillary and/or internal mammary nodes (on sentinel biopsy);  RFS, recurrence-free survival; RW, real world; STEEP: standardised Definitions for Efficacy End Points; T, tumour size.

Reference

1. KISQALI^® (ribociclib). Summary of Product Characteristics.

2. Jhaveri K, et al. Poster 235P. Presented at ESMO BC 2026. 6–8 May, Berlin, Germany.

UK | August 2026 | FA-11746333