PDF(Pubmed)
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 < 0.001.
CONCLUSIONS: We confirmed that gender minorities are severely underrepresented among BC registration trials. We observed a lower rate of men in trials envisaging endocrine manipulation or in less contemporary trials. This work sought to urge the scientific community to increase the awareness level towards the issue of gender minorities and to endorse more inclusive criteria in 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 < 0.001.
CONCLUSIONS: We confirmed that gender minorities are severely underrepresented among BC registration trials. We observed a lower rate of men in trials envisaging endocrine manipulation or in less contemporary trials. This work sought to urge the scientific community to increase the awareness level towards the issue of gender minorities and to endorse more inclusive criteria in clinical trials.
摘要：
背景：最近几年，乳腺癌（BC）生存率得到了前所未有的改善。然而,这完全适用于女性BC患者，由于性别少数群体(男性，变性者/性别多样化）在BCIII期注册临床试验中被忽略。
方法：我们对目前位于BC治疗算法内的药物的III期临床试验进行了范围审查。
结果：我们选择了51项III期试验。35.3%的试验允许男性入组。在试验纳入/排除标准中，没有一个涉及跨性别/性别多样化的人。与历史群体相比，当代男性的入学率更高。我们发现药物类别与包括男性的可能性之间存在统计学上的显着关联：100％，80%,50%,33.3%,25%,10%和9.1%的试验测试ICI/PARP-i，ADC,PI3K/AKT/mTOR-i,抗HER2治疗,CDK4/6-i,ET独自一人，只有CT。总的来说,77409名患者入选，包括112名男性(0.2%)。没有一项试验报告跨性别/性别多样化的人群比例。调查PARP-i的研究与最高比例的男性（1.42％）显着相关，虽然CT试验的发生率最低(0.13%)，仅ET（0.10%），和CDK4/6-I(0.08%)，p<0.001。
结论：我们证实，在BC登记试验中，性别少数群体的比例严重不足。我们在设想内分泌操纵的试验中或在不太现代的试验中观察到男性的比率较低。这项工作旨在敦促科学界提高对性别少数群体问题的认识，并在临床试验中认可更具包容性的标准。
方法：我们对目前位于BC治疗算法内的药物的III期临床试验进行了范围审查。
结果：我们选择了51项III期试验。35.3%的试验允许男性入组。在试验纳入/排除标准中，没有一个涉及跨性别/性别多样化的人。与历史群体相比，当代男性的入学率更高。我们发现药物类别与包括男性的可能性之间存在统计学上的显着关联：100％，80%,50%,33.3%,25%,10%和9.1%的试验测试ICI/PARP-i，ADC,PI3K/AKT/mTOR-i,抗HER2治疗,CDK4/6-i,ET独自一人，只有CT。总的来说,77409名患者入选，包括112名男性(0.2%)。没有一项试验报告跨性别/性别多样化的人群比例。调查PARP-i的研究与最高比例的男性（1.42％）显着相关，虽然CT试验的发生率最低(0.13%)，仅ET（0.10%），和CDK4/6-I(0.08%)，p<0.001。
结论：我们证实，在BC登记试验中，性别少数群体的比例严重不足。我们在设想内分泌操纵的试验中或在不太现代的试验中观察到男性的比率较低。这项工作旨在敦促科学界提高对性别少数群体问题的认识，并在临床试验中认可更具包容性的标准。
