In this study, patients with stage II and III hormone receptor-positive, HER2-negative breast cancer (including some patients whose lymph nodes were not affected but who had high-risk features) either took ribociclib tablets for three years after surgery on top of anti-hormone tablets, or took the anti-hormone tablets alone. After about five years, adding ribociclib lowered the risk of the cancer coming back, and this benefit grew over time. The effect on length of life is still being studied. Decisions about treatment should be made with the treating doctor.
HR-positive/HER2-negative stage IIB–III, or stage IIA with nodal involvement, or node-negative stage IIA with grade 3, or grade 2 with Ki-67 ≥20% or high genomic risk
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Ribociclib | 400 mg once daily | Oral | Days 1–21, every 28 days |
| Letrozole or anastrozole (± goserelin) | 2.5 or 1 mg daily | Oral | Continuous |
Liver tests and blood counts: after the first 2 cycles, at the start of each of the next 4 cycles. Dose reduction: 200 mg daily; below that, discontinue.
HR-positive/HER2-negative stage II and III at high risk of recurrence
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Ribociclib | 400 mg (2 × 200 mg tablets) | Oral, with or without food, preferably in the morning | Once daily, days 1 to 21, every 28 days |
| Letrozole or anastrozole | 2.5 mg or 1 mg | Oral | Daily, continuously |
| Pre- or perimenopausal women and men | |||
| Goserelin | 3.6 mg | Subcutaneous | Day 1, every 28 days |
Accompanying doses as described for NATALEE in the FDA label. The only dose reduction level: 200 mg a day.
On the page “Ribociclib (Kisqali)” · Standard doses (FDA label)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Ribociclib 400 mg orally daily (3 weeks on, 1 week off) for 36 months, with letrozole 2.5 mg or anastrozole 1 mg daily for 60 months; premenopausal women and men also received goserelin 3.6 mg every 28 days. If ribociclib was interrupted for more than 28 days because of a related adverse event, ribociclib was discontinued, and discontinuation of the NSAI required discontinuation of ribociclib.
Letrozole 2.5 mg or anastrozole 1 mg daily for 60 months; premenopausal women and men also received goserelin 3.6 mg every 28 days.
Source of the regimen details: Full text of the paper (ESMO Open 2025; open access PMC12684762, Methods section)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Pre- and postmenopausal women and men with HR-positive/HER2-negative early breast cancer of anatomical stage IIA (N1, or N0 with high-risk features), IIB or III.
Primary endpoint: invasive disease-free survival (iDFS). Secondary/exploratory endpoints: distant disease-free survival, recurrence-free survival, distant recurrence-free survival and overall survival.
Safety data are not given in the abstract of this report; see the full text.
This report shows that the iDFS benefit of adjuvant ribociclib persists and grows after the end of 3 years of treatment, including in high-risk N0 patients; overall survival is not yet statistically conclusive.
The trial was open-label; P values in this report are nominal and overall survival is still immature. Safety data and exact patient numbers are in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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