Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study

NCT06234488 | Active Not Recruiting

• 1 other identifier: PRO00043417
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 22

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Breast Cancer Diagnosis Method

  Describe 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.

  33 years

• Breast Cancer Risk Factors

  Assess 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.

  33 years

• Breast Cancer Management Strategies

  Report 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.

  33 years

• Outcomes Data

  Breast 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.

  33 years

Study Arms (1)

Transgender and Gender-Diverse Persons with Breast Cancer

Patients who had a breast cancer diagnosis (including those with ductal carcinoma in situ (DCIS)), who were age ≥18 years at the time of diagnosis and identify as a gender and/or sex that is different from their sex assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender and gender-diverse persons (TGD)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients are those who had a breast cancer diagnosis (including those with ductal carcinoma in situ (DCIS), who were age ≥18 years at the time of diagnosis and identify as a gender and/or sex that is different from the sex they were assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.

You may qualify if:

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

You may not qualify if:

• Age \<18 at time of breast cancer diagnosis
• Cis-gendered persons

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (22)

University of Southern California/Los Angeles (USC/LA County)

Los Angeles, California, 90089, United States

Location

University of California San Francisco (UCSF)

San Francisco, California, 94115, United States

Location

University of Colorado Anschutz Medical Campus (CU Anschutz)

Aurora, Colorado, 80045, United States

Location

MedStar Georgetown University Hospital (MGUH)

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Moffitt Cancer Center (MCC)

Tampa, Florida, 33612, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Birgham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University (Boston U)

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

New York University (NYU)

New York, New York, 10012, United States

Location

University of Rochester

Rochester, New York, 14623, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation (CCF)

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, 37232, United States

Location

University of Washington (UW)

Seattle, Washington, 98195, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Chandler S Cortina

  The Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: December 8, 2023
• Primary Completion: November 1, 2024
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (22)