Exclusion of Male Patients in Breast Cancer Clinical Trials

Duma, Narjust; Hoversten, Katherine P.; Ruddy, Kathryn J.

doi:10.1093/jncics/pky018

Cited by 24 publications

(18 citation statements)

References 9 publications

(12 reference statements)

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“…Male breast cancer (MBC) is a rare disease, comprising 1% of all breast cancer cases . Due to its rarity, to our knowledge prospective clinical trials specifically focused on MBC have not been conducted . However, the incidence of MBC has been noted to be rising over the past few decades, and there is an increasing appreciation of differences in the tumor biology of female breast cancer versus MBC, thereby highlighting the need for studies focused on this unique population.…”

Section: Introductionmentioning

confidence: 99%

Male breast cancer in the United States: Treatment patterns and prognostic factors in the 21st century

Yadav

Karam

Riaz

et al. 2019

Cancer

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103

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Background Male breast cancer (MBC) is a rare disease for which there is limited understanding of treatment patterns and prognostic factors. Methods Men with TNM stage I to stage III breast cancer diagnosed between 2004 and 2014 in the National Cancer Data Base were included. Trends in treatment modalities were described using the average annual percentage change (AAPC) and estimated using Joinpoint software for the analysis of trends. Kaplan‐Meier curves and the multivariate Cox proportional hazards regression model were used to compare survival between subgroups and to identify prognostic factors. Results A total of 10,873 MBC cases were included, with a median age at diagnosis of 64 years. Breast‐conserving surgery was performed in 24% of patients, and 70% of patients undergoing breast conservation received radiotherapy. Approximately 44% of patients received chemotherapy, and 62% of patients with estrogen receptor–positive disease received endocrine therapy. Oncotype DX was ordered in 35% of patients with lymph node–negative, estrogen receptor–positive/human epidermal growth factor receptor 2 (HER2)‐negative tumors. During the study period, there was a significant increase in the rates of total mastectomy, contralateral prophylactic mastectomy, radiotherapy after breast conservation, ordering of Oncotype DX, and the use of endocrine therapy (P < .05). On multivariate analysis, factors found to be associated with worse overall survival were older age, black race, higher Charlson Comorbidity Index, high tumor grade and stage of disease, and undergoing total mastectomy. Residing in a higher income area; having progesterone receptor–positive tumors; and receipt of chemotherapy, radiotherapy, and endocrine therapy were associated with better overall survival. Conclusions Despite the lack of prospective randomized trials in patients with MBC, the results of the current study demonstrated that the treatment of this disease has evolved over the years. These findings further the understanding of the modern treatment and prognosis of MBC, and identify several areas for further research.

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Section: Introductionmentioning

confidence: 99%

Male breast cancer in the United States: Treatment patterns and prognostic factors in the 21st century

Yadav

Karam

Riaz

et al. 2019

Cancer

Self Cite

103

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“…This was accompanied by a greater interest from the scientific community in broadening the understanding of the tumorigenesis of BC in men, and it seems to be clear that the vast knowledge generated so far about female breast cancer (FBC) cannot be completely transposed to MBC [ 10 ]. Despite this, especially due to the rarity of the disease and the difficulty in designing clinical trials focused on this population, as well as the underrepresentation of men on existing studies [ 11 ], the treatment of MBC still follows the same recommendations for FBC [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Genetic Landscape of Male Breast Cancer

Campos

Rouleau

Torrezan

et al. 2021

Cancers

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Male breast cancer (MBC) is now considered molecularly different from female breast cancer (FBC). Evidence from studies indicates that common genetic and epigenetic features of FBC are not shared with those diagnosed in men. Genetic predisposition is likely to play a significant role in the tumorigenesis of this rare disease. Inherited germline variants in BRCA1 and BRCA2 account for around 2% and 10% of MBC cases, respectively, and the lifetime risk of breast cancer for men harboring BRCA1 and BRCA2 mutations is 1.2% and 6.8%. As for FBC, pathogenic mutations in other breast cancer genes have also been recently associated with an increased risk of MBC, such as PALB2 and CHEK2 mutations. However, while multigene germline panels have been extensively performed for BC female patients, the rarity of MBC has resulted in limited data to allow the understanding of the magnitude of risk and the contribution of recently identified moderate penetrance genes of FBC for MBC predisposition. This review gathers available data about the germline genetic landscape of men affected by breast cancer, estimated risk associated with these genetic variants, and current guidelines for clinical management.

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“…In addition, men are frequently excluded from breast cancer trials, as shown by a recent report; between 2000 and 2017, of 426 trials retrieved in breast cancer, 65% excluded males. 27 Overall, 0.42% of participants were male, with the lowest enrolment rates in hormonal and targeted therapy trials (0.1% and 0.1%, respectively). This paradigm should shift in the future given the FDA call to include men in BC trials.…”

Section: Discussionmentioning

confidence: 94%

Management and outcome of male metastatic breast cancer in the national multicenter observational research program Epidemiological Strategy and Medical Economics (ESME)

et al. 2020

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Background and Aims: Because of its low prevalence, metastatic breast cancer (MBC) in males is managed based on clinical experience with women. Using a real-life database, we aim to provide a comprehensive analysis of male MBC characteristics, management and outcome. Methods: The Epidemiological Strategy and Medical Economics Data Platform collected data for all men and women ⩾18 years with MBC in 18 participating French Comprehensive Cancer Centers from January 2008 to November 2016. Demographic, clinical, and pathological characteristics were retrieved, as was treatment modality. Men were matched 1:1 to women with similar characteristics. Results: Of 16,701 evaluable patients, 149 (0.89%) men were identified. These men were older (median age 69 years) and predominantly had hormone receptor HR+/HER2– disease (78.3%). Median overall survival (OS) was 41.8 months [95% confidence interval (CI: 26.9–49.7)] and similar to women. Median progression-free survival (PFS) with first-line therapy was 9.3 months [95% CI (7.4–11.5)]. In the HR+/HER2– subpopulation, endocrine therapy (ET) alone was the frontline treatment for 43% of patients, including antiestrogens ( n = 19), aromatase inhibitors ( n = 15) with luteinizing hormone-releasing hormone (LHRH) analogs ( n = 3), and various sequential treatments. Median PFS achieved by frontline ET alone was similar in men [9.8 months, 95% CI (6.9–17.4)] and in women [13 months, 95% CI (8.4–30.9)] ( p = 0.80). PFS was similar for HR+/HER2– men receiving upfront ET or chemotherapy: 9.8 months [95% CI (6.9–17.4)] versus 9.5 months [95% CI (7.4–11.7)] ( p = 0.22), respectively. Conclusion: MBC management in men and women leads to similar outcomes, especially in HR+/HER2– patients for whom ET should also be a cornerstone. Unsolved questions remain and successfully recruiting trials for men are still lacking.

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Exclusion of Male Patients in Breast Cancer Clinical Trials

Cited by 24 publications

References 9 publications

Male breast cancer in the United States: Treatment patterns and prognostic factors in the 21st century

Male breast cancer in the United States: Treatment patterns and prognostic factors in the 21st century

Genetic Landscape of Male Breast Cancer

Management and outcome of male metastatic breast cancer in the national multicenter observational research program Epidemiological Strategy and Medical Economics (ESME)

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