MONALEESA-7
Trial question
What is the effect of ribociclib plus endocrine therapy in patients with HR+/HER2- advanced breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
672 female patients.
Inclusion criteria: adult patients with hormone-receptor-positive/HER2- advanced breast cancer.
Key exclusion criteria: receipt of prior CDK4/6 inhibitor therapy; postmenopausal women; inflammatory breast cancer; prior hormonal anti-cancer therapy for advanced breast cancer; concurrent malignancy or malignancy within 3 years or randomization; CNS metastases; active cardiac disease or a history of cardiac dysfunction.
Interventions
N=335 ribociclib plus endocrine therapy (ribociclib 600 mg PO daily for 21 consecutive days, followed by 7 days off, for a complete cycle of 28 days plus nonsteroidal aromatase inhibitor/tamoxifen 20 mg PO daily and goserelin 3.6 mg SC).
N=337 placebo plus endocrine therapy (matching placebo on days 1-21 of each 28-day cycle plus nonsteroidal aromatase inhibitor/tamoxifen 20 mg/day PO and goserelin 3.6 mg SC).
Primary outcome
Overall survival at 42 months
70.2%
46%
70.2 %
52.7 %
35.1 %
17.6 %
0.0 %
Ribociclib plus endocrine
therapy
Placebo plus endocrine
therapy
Significant
increase ▲
NNT = 4
Significant increase in overall survival at 42 months (70.2% vs. 46%; HR 1.41, 95% CI 1.05 to 1.85).
Secondary outcomes
Significant increase in patients who had not yet received a first subsequent chemotherapy (65.8% vs. 49%; HR 1.67, 95% CI 1.3 to 2.17).
Significant increase in progression-free survival during receipt of subsequent therapy at 42 months (54.6% vs. 37.8%; HR 1.45, 95% CI 1.15 to 1.82).
Significant increase in overall survival at 42 months, patients who received an aromatase inhibitor (69.7% vs. 43%; HR 1.43, 95% CI 1.02 to 2).
Safety outcomes
No significant difference in prolonged QT interval.
Significant difference in grade 3 or 4 neutropenia (63.5% vs. 4.5%).
Conclusion
In adult patients with hormone-receptor-positive/HER2- advanced breast cancer, ribociclib plus endocrine therapy was superior to placebo plus endocrine therapy with respect to overall survival at 42 months.
Reference
Seock-Ah Im, Yen-Shen Lu, Aditya Bardia et al. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316.
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