Breast CancerNCT06234488
Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study
An observational study of Breast Cancer and Breast Neoplasms, run by Medical College of Wisconsin at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Adenocarcinoma
- How many people
- 125 participants
- Where
- 22 sitesUnited States
- Study dates
- 8 Dec 2023to 25 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age <18 at time of breast cancer diagnosis
- Cis-gendered persons
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Anschutz Medical Campus (CU Anschutz)
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Birgham and Women's Hospital
Boston, Massachusetts, 02115
Boston University (Boston U)
Boston, Massachusetts, 02118
Northwestern Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation (CCF)
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
NorthShore University Health System
Evanston, Illinois, 60201
Mayo Clinic
Jacksonville, Florida, 32224
University of Southern California/Los Angeles (USC/LA County)
Los Angeles, California, 90089
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37232
New York University (NYU)
New York, New York, 10012
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14623
University of California San Francisco (UCSF)
San Francisco, California, 94115
University of Washington (UW)
Seattle, Washington, 98195
Moffitt Cancer Center (MCC)
Tampa, Florida, 33612
MedStar Georgetown University Hospital (MGUH)
Washington D.C., District of Columbia, 20007
About this study
Official title: A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
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, Breast Neoplasms, Breast Adenocarcinoma, Breast Cancer Stage, Breast Cancer Stage IV, Breast Cancer Invasive
- Keywords
- Transgender, Breast Cancer, Nonbinary, Gender Diverse, Gender-Affirming Hormone Therapy
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 33 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start8 Dec 2023
- Primary completion1 Nov 2024
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandler S Cortina, Medical College of Wisconsin
- Investigators
- Chandler S Cortina, Principal investigator, The Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234488
- Sponsor's protocol ID
- PRO00043417
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals
- ClinicalTrials.gov ID
- NCT06234488
- Acronym / sponsor ID
- PRO00043417
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Adenocarcinoma, Breast Cancer Stage, Breast Cancer Stage IV, Breast Cancer Invasive
- Keywords
- Transgender, Breast Cancer, Nonbinary, Gender Diverse, Gender-Affirming Hormone Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age <18 at time of breast cancer diagnosis
- Cis-gendered persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast Cancer Diagnosis Method
Time frame: 33 years
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.
Breast Cancer Risk Factors
Time frame: 33 years
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.
Breast Cancer Management Strategies
Time frame: 33 years
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.
Outcomes Data
Time frame: 33 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandler S Cortina principal investigator
The Medical College of Wisconsin
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Neoplasms, run by Medical College of Wisconsin at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Diagnosis Method (time frame: 33 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.