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Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).
Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.
Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.
Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.
Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1
Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).
Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.
Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.
Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.
Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1
Key clinical point: Ribociclib plus letrozole was safe and effective in male patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (BC) who did not receive prior endocrine therapy (ET).
Major finding: Male patients vs. overall population experienced fewer treatment-related adverse events (AE), especially neutropenia (all grade 53.8% vs. 74.5%; grade ≥3 41.0% vs. 57.2%). After a median follow-up of 25.4 months, median time to progression was 27.1 months for the overall cohort vs. not reached in males.
Study details: Findings are from an exploratory analysis of the phase 3b CompLEEment-1 trial including 39 males with HR-positive HER2-negative advanced BC who received ribociclib+letrozole but not prior ET for the advanced disease.
Disclosures: The study was supported by Novartis Pharmaceuticals. The authors declared serving as members of speakers’ bureau or receiving honoraria, advisory/consulting fees, expert testimony fees, research grants, or travel and accommodation expenses from several sources, including Novartis. Two authors declared being employees or shareholders of Novartis.
Source: Campone M et al. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 (Feb 25). Doi: 10.1007/s10549-022-06543-1