Prescribing information (external link)

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Risk of recurrence in HR+/HER2– eBC

Indications:1

 

  • KISQALI 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- or 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.1

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

Please consult your local Summary of Product Characteristics for the full KISQALI safety and tolerability profiles.

Patients with HR+/HER2− eBC remain at risk of recurrence, despite current SoC*2,3

*Meta-analysis of data for risk of recurrence from 14 Phase III clinical trials (n=30,139), including 4 of adjuvant CDK4/6i therapy, in patients with Stage I–III HR+/HER2− eBC with any nodal involvement, who had received 5 years of standard of care (SoC) adjuvant endocrine therapy and chemotherapy. iDFS or DFS were reported at 3 and 5 years post-randomisation. Meta-analysis performed on pooled 5-year data revealed a 12% risk of invasive recurrence for the overall population, regardless of stage or nodal status.2

Recurrence in a retrospective real-world analysis of 7564 patients with HR+/HER2− eBC from the US Flatiron database.†3

Patients with N1 and high-risk N0 eBC share a similar recurrence risk.3

Graph showing overall recurrence % for NO, N1 and N2-3 groups up to 6 years.

Adapted from Jhaveri K, et al. 2024.3

In oestrogen receptor-positive (ER+) eBC ~50% of relapses occur within the first 5 years, with a peak around 4 years.§4

Chart showing recurrence in ER+ and ER- patients by time to metastasis up to 20 years.

Adapted from Gomis RR, et al. 2017.4

Retrospective real-world data observed a high potential recurrence burden in adult patients with HR+/HER2– eBC5

Retrospective real-world study of adult patients with Stage I–III HR+/HER2− eBC in the UK Cancer Analysis System. The sample was divided into two cohorts:

  1. the main cohort of patients with HR+/ HER2− eBC [n=84,506]

  2. a subset of patients matched, as close as possible, to the eligibility criteria of the NATALEE trial (NATALEE-like; n=37,446)5

The NATALEE-like cohort comprised ~44% of the main cohort, but the majority of patients with recurrences.5

Pie chart with the text 68% of all recurrences.
Pie chart with the text 79% of metastatic recurrences.
Speech box with the text 'The high percentage of metastatic recurrence in the NATALEE-like cohort represents a high-cost burden, £39,508 per year, with the key cost driver being overall inpatient hospitalisations, at 13.43 hospitalisations per year.
Blue callout with the text ‘There is a need for treatments that help reduce risk of recurrence to lessen the disease burden of HR+/HER2– eBC in UK patients.’

Use our tool to see if your patients with HR+/HER2– eBC could be eligible for treatment with KISQALI + AI

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Learn about the efficacy data of KISQALI + AI in the NATALEE trial

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†Kaplan–Meier analysis started at initial diagnosis date. Patients without an event were censored on their last confirmed structured activity date.3
‡N0 high-risk was defined by the NATALEE trial eligibility criteria: T4N0, T3N0, or T2N0 with additional criteria (G2 with Ki-67 ≥20% or high genomic risk, or G3).3
§5 years from diagnosis and surgical removal of the primary tumour.4

AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; DFS, disease-free survival; eBC, early breast cancer; ER+, oestrogen receptor-positive; ER–, oestrogen receptor-negative; G, tumour grade; HER2−, human epidermal growth factor receptor negative; HR+, hormone-receptor positive; iDFS, invasive disease-free survival; LHRH, luteinising hormone-releasing hormone; N, node grade; RoR, risk of recurrence; SoC, standard of care; T, tumour stage.

References

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

  2. Curigliano G, et al. J Clin Oncol 2024;42(suppl 16): abstract 541.

  3. Jhaveri K, et al. Poster 292P. Presented at the European Society for Medical Oncology Congress. 13–17 September 2024, Barcelona, Spain.

  4. Gomis RR, et al. Mol Oncol 2017;11(1):62–78.

  5. Johnston S, et al. P144P. Presented at the European Society for Medical Oncology Breast Cancer Annual Congress. 14–17 May 2025, Munich, Germany.

UK | April 2026 | FA-11633300

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.