Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer
- Study type
- Clinical trial
- Study name
- MONALEESA-3
- Phase
- Phase 3
- Design
- Randomised (2:1 ratio), placebo-controlled trial; protocol-specified second interim analysis of overall survival
- Sample size
- 726 patients (484 in the ribociclib group and 242 in the placebo group)
- Source
- N Engl J Med · 2020
- Trial registration
- NCT02422615
In plain words
In this study, women past menopause who had advanced hormone-positive, HER2-negative breast cancer received either ribociclib plus fulvestrant or a placebo (dummy pill) plus fulvestrant. Adding ribociclib helped patients live longer: after 42 months about 58% of patients in the ribociclib group were alive, compared with about 46% in the placebo group. No new safety concerns were seen in this study.
Key results
Treatment arms and regimens
Ribociclib plus fulvestrant, as first-line or second-line therapy (484 patients).
Ribociclib 600 mg orally daily, days 1 to 21 of each 28-day cycle + fulvestrant 500 mg intramuscularly on day 1 of each cycle with an additional dose on day 15 of cycle 1; until progression or unacceptable toxicity (dose modifications allowed).
Placebo plus fulvestrant, as first-line or second-line therapy (242 patients).
Placebo on days 1 to 21 every 28 days + fulvestrant 500 mg intramuscularly on day 1 of each cycle and day 15 of cycle 1.
Source of the regimen details: ClinicalTrials.gov NCT02422615 and the FDA label for Kisqali (DailyMed, section 14)
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.
Study population
Postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received ribociclib or placebo as first-line or second-line therapy, together with fulvestrant.
Endpoints
This paper reports the protocol-specified second interim analysis of overall survival. Survival was assessed with a stratified log-rank test and summarised with the Kaplan–Meier method. Progression-free survival (PFS) in patients receiving first-line treatment was also updated descriptively.
Safety and side effects
No new safety signals were observed. Exact rates of grade ≥3 adverse events are not given in the abstract and are available in the full text.
Clinical significance and place in guidelines
This analysis showed that adding ribociclib to fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer improves overall survival as well as progression-free survival, and supports use of this combination as first-line or second-line therapy. Regulatory approvals and guideline recommendations should be checked separately, as they are not mentioned in the abstract.
Limitations
This report is the second interim analysis of overall survival. The benefit was consistent across “most” subgroups, not all of them. The PFS update was descriptive only. Dosing details and exact adverse event rates are not in the abstract; the full text should be consulted.
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.