e-Article
Gender minorities in breast cancer – Clinical trials enrollment disparities: Focus on male, transgender and gender diverse patients
Document Type
article
Author
Federica Miglietta; Letizia Pontolillo; Carmine De Angelis; Roberta Caputo; Monica Marino; Emilio Bria; Rossana Di Rienzo; Annarita Verrazzo; Carlo Buonerba; Giampaolo Tortora; Giuseppe Di Lorenzo; Lucia Del Mastro; Mario Giuliano; Filippo Montemurro; Fabio Puglisi; Valentina Guarneri; Michelino De Laurentiis; Luca Scafuri; Grazia Arpino
Source
Breast, Vol 75, Iss , Pp 103713- (2024)
Subject
Language
English
ISSN
1532-3080
Abstract
Background: The last years have seen unprecedented improvement in breast cancer (BC) survival rates. However, this entirely apply to female BC patients, since gender minorities (male, transgender/gender-diverse) are neglected in BC phase III registration clinical trials. Methods: We conducted a scoping review of phase III clinical trials of agents with a current positioning within the therapeutic algorithms of BC. Results: We selected 51 phase III trials. Men enrollment was allowed in 35.3% of trials. In none of the trial inclusion/exclusion criteria referred to transgender/gender-diverse people. A numerical higher rate of enrolled men was observed in the contemporary as compared to historical group.We found a statistically significant association between the drug class and the possibility of including men: 100%, 80%, 50%, 33.3%, 25%, 10% and 9.1% of trials testing ICI/PARP-i, ADCs, PI3K/AKT/mTOR-i, anti-HER2 therapy, CDK4/6-i, ET alone, and CT alone.Overall, 77409 patients were enrolled, including 112 men (0.2%). None of the trial reported transgender/gender-diverse people proportion. Studies investigating PARP-i were significantly associated with the highest rate of enrolled men (1.42%), while the lowest rates were observed for trials of CT (0.13%), ET alone (0.10%), and CDK 4/6-I (0.08%), p