Breast Cancer Regimen Safety, Efficacy in Men Similar to All Patients, Study Finds


Ribociclib plus letrozole was found safe and effective for the treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer in men. These findings were published in Breast Cancer Research and Treatment.

Historically, men have not been included in clinical trials for breast cancer. However, due to the increasing prevalence of breast cancer in men, the US Food and Drug Administration now recommends including men in trials.

The Compleement-1 trial ( Identifier: NCT02941926) was a single-arm, open-label, multicenter phase 3b study of ribociclib plus letrozole for the treatment of HR+ HER2− advanced breast cancer. The trial was conducted between 2016 and 2018 and included 3246 female and male patients.

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For the current analysis, data from the 39 men in the trial were evaluated for safety and efficacy. The men had a median age of 62.0 years (range, 33 to 80), 71.8% were White, and 46.2% had an Eastern Cooperative Oncology Group (ECOG) performance score of 1-2.

Most men reported adverse events (97.4%) and treatment-related events (92.3%). One male patient reported a serious treatment-related event. Four men discontinued treatment due to adverse events, 28 had a dose adjustment or interruption due to adverse events, and 30 experienced an event requiring additional therapy.

Observed trends in safety and tolerability were similar between the entire cohort (of male and female patients) and among male patients only.

Efficacy outcomes were also similar between the all-male and all-patient cohorts, including overall response rates (46.9% and 43.6%, respectively), clinical benefit rates (71.9% vs 69.1%), partial response rates (43.8% vs 40.9%), and complete response rates (3.1% vs 2.7%).

These data support the use of ribociclib plus letrozole in men with HR+ HER2− advanced breast cancer, according to researchers.

Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Campone M, De Laurentiis M, Zamagni C, 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;193(1):95-103. doi:10.1007/s10549-022-06543-1

This article originally appeared on Oncology Nurse Advisor

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