Skip to content

Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study

A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06234488
Enrollment
125
Registered
2024-01-31
Start date
2023-12-08
Completion date
2026-08-25
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Adenocarcinoma, Breast Cancer, Breast Cancer in Situ, Breast Cancer Invasive, Breast Cancer Stage, Breast Cancer Stage IV, Breast Neoplasms

Keywords

Transgender, Breast Cancer, Nonbinary, Gender Diverse, Gender-Affirming Hormone Therapy

Brief summary

There is no granular retrospective data on breast cancer in transgender and gender-diverse (TGD) persons from a contemporary and diverse American cohort. The purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of TGD persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.

Interventions

None listed

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 years of age or older 2. Breast cancer diagnosis (including DCIS) 3. Persons who identify as gender and/or sex that is different from the sex they were assigned at birth

Exclusion criteria

1. Age \<18 at time of breast cancer diagnosis 2. Cis-gendered persons

Design outcomes

Primary

MeasureTime frameDescription
Breast Cancer Diagnosis Method33 yearsDescribe the method of breast cancer diagnosis (self detected vs screen detected vs healthcare provider detected) and compare to the published data from cisgender women by determining means and standard deviation and comparing rates using the Wilcoxon signed-rank test.
Breast Cancer Risk Factors33 yearsAssess breast cancer risk factors (family history, genetics, etc.), including a prior use of gender-affirming hormone therapy and/or gender-affirming surgery on tumor receptor status and stage at diagnosis using t-test and chi-squared test.
Breast Cancer Management Strategies33 yearsReport breast cancer management strategies (type of breast surgery, receipt of radiation, etc.) through descriptive and comparative staststics with a focus on the use of adjuvant endocrine therapy and gender-affirming hormone therapy for patients with hormone-receptor positive disease using t-test and chi-squared test.
Outcomes Data33 yearsBreast cancer local and distant recurrence, overall survival, and disease-free survival using Kaplan-Meier analysis. Cox Proportional Hazards model will be used to estimate the effect of various factors on distant metastasis-free and overall survival.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChandler S Cortina

The Medical College of Wisconsin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026