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Key clinical point: With an extended median follow-up of 53.5 months, ribociclib+endocrine therapy (ET) continued to prolong survival vs placebo+ET in pre-/perimenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: Ribociclib vs placebo prolonged the median overall survival in overall population (58.7 months vs 48 months; hazard ratio [HR], 0.76; 95% CI, 0.61-0.96) and in women aged <40 years (51.3 months vs 40.5 months; HR, 0.65; 95% CI, 0.43-0.98). No new safety signals were identified.
Study details: Findings are from an exploratory analysis of phase 3 MONALEESA-7 trial including 672 pre- or perimenopausal women with HR+/HER2− advanced BC who were randomly assigned to ET+ribociclib or ET+placebo.
Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors reported receiving grants, nonfinancial support, and advisory and personal fees from Novartis and other sources. Six authors declared being employees and shareholders of Novartis.
Source: Lu YS et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-3032.
Key clinical point: With an extended median follow-up of 53.5 months, ribociclib+endocrine therapy (ET) continued to prolong survival vs placebo+ET in pre-/perimenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: Ribociclib vs placebo prolonged the median overall survival in overall population (58.7 months vs 48 months; hazard ratio [HR], 0.76; 95% CI, 0.61-0.96) and in women aged <40 years (51.3 months vs 40.5 months; HR, 0.65; 95% CI, 0.43-0.98). No new safety signals were identified.
Study details: Findings are from an exploratory analysis of phase 3 MONALEESA-7 trial including 672 pre- or perimenopausal women with HR+/HER2− advanced BC who were randomly assigned to ET+ribociclib or ET+placebo.
Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors reported receiving grants, nonfinancial support, and advisory and personal fees from Novartis and other sources. Six authors declared being employees and shareholders of Novartis.
Source: Lu YS et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-3032.
Key clinical point: With an extended median follow-up of 53.5 months, ribociclib+endocrine therapy (ET) continued to prolong survival vs placebo+ET in pre-/perimenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).
Major finding: Ribociclib vs placebo prolonged the median overall survival in overall population (58.7 months vs 48 months; hazard ratio [HR], 0.76; 95% CI, 0.61-0.96) and in women aged <40 years (51.3 months vs 40.5 months; HR, 0.65; 95% CI, 0.43-0.98). No new safety signals were identified.
Study details: Findings are from an exploratory analysis of phase 3 MONALEESA-7 trial including 672 pre- or perimenopausal women with HR+/HER2− advanced BC who were randomly assigned to ET+ribociclib or ET+placebo.
Disclosures: This study was funded by Novartis Pharmaceuticals Corporation. The authors reported receiving grants, nonfinancial support, and advisory and personal fees from Novartis and other sources. Six authors declared being employees and shareholders of Novartis.
Source: Lu YS et al. Clin Cancer Res. 2021 Dec 29. doi: 10.1158/1078-0432.CCR-21-3032.