130 Participants Needed

Hormone Therapy for Breast Cancer

CS
Overseen ByChandler S Cortina, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
Must be taking: Gender-affirming hormones
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how hormone therapy affects breast cancer screening. It gathers data from breast imaging and examines the experiences and perceptions of individuals on hormone therapy undergoing screening. The trial also identifies barriers to effective breast cancer screening. Individuals who have been on hormone therapy for at least 9 months, have family members with breast cancer, and can communicate in English might be suitable participants. As an unphased trial, it provides a unique opportunity to contribute to understanding and improving breast cancer screening for those on hormone therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on individuals already on hormone therapy, so you may be able to continue your current treatment.

What prior data suggests that this breast cancer screening method is safe for individuals on hormone therapy?

Research has shown that hormone therapy can increase the risk of breast cancer, particularly for those with a history of the disease. This means that using hormone therapy raises the chance of breast cancer recurrence. However, cancers that develop in individuals using hormone therapy often grow more slowly and may be less aggressive. Careful consideration of these risks is important.

The safety of hormone therapy has been extensively studied. While it is used for various treatments, the risk of breast cancer remains a significant factor, especially for those with a previous diagnosis. Discussing these risks with a doctor is advisable to make an informed decision.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve breast cancer screening for individuals on hormone therapy by using a combination of standard mammography and whole breast ultrasound. Unlike traditional screening methods that might not account for the unique needs of those on hormone therapy, this approach gathers more comprehensive imaging data. Additionally, it seeks to enhance the screening process by understanding the experiences and perceptions of both patients and healthcare providers. This could lead to more personalized, equitable, and effective breast cancer screening protocols in the future.

What evidence suggests that hormone therapy is effective for breast cancer screening?

Research has shown that hormone therapy can affect breast cancer risk, highlighting the importance of regular screening. In this trial, individuals on hormone therapy will undergo breast imaging, including standard screening mammography and whole breast ultrasound. Studies have found that regular mammograms have led to a 28% reduction in breast cancer deaths among women aged 40 and older. Regular mammograms effectively detect breast cancer early. However, the benefits and potential downsides can vary based on factors such as age and breast density. People on hormone therapy should consider these factors when discussing screening options with their healthcare providers.24678

Who Is on the Research Team?

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Chandler S Cortina, MD, MS

Principal Investigator

The Medical College of Wisconsin

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been on hormone therapy for gender transition for at least 9 months.
I can speak, read, and write in English.
I can understand and am willing to sign the informed consent document.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Breast Imaging and Data Collection

Participants undergo breast imaging, including standard screening mammography and whole breast ultrasound, and data is collected on gender-affirming therapy and family cancer history.

3.5 years
Regular imaging visits as per study protocol

Qualitative Data Collection

Participants complete surveys and participate in interviews to gather qualitative data on their experiences and perceptions of breast cancer screening.

3.5 years
Interviews and surveys conducted periodically

Follow-up

Participants are monitored for callback and biopsy rates after breast cancer screening.

3.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Hormone Therapy

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Individuals on Hormone TherapyExperimental Treatment2 Interventions
Group II: Breast Imaging StakeholdersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Citations

Outcomes of Screening Mammography by Frequency, Breast ...

One study supporting our findings found that mammography every 3 to 4 years was cost-effective for women aged 50 to 79 years with fatty breasts and no other ...

Outcomes of Screening Mammography by Frequency ...

Objective To compare the benefits and harms of screening mammography frequencies according to age, breast density, and postmenopausal hormone ...

Effect of Three Decades of Screening Mammography on ...

Among women 40 years of age or older, deaths from breast cancer decreased from 71 to 51 deaths per 100,000 women — a 28% decrease. This ...

Breast Cancer Risk Assessment and Screening in Average ...

The review reported results from the Breast Cancer Surveillance Consortium that noted a 10-year, cumulative false-positive rate of 61% with annual screening and ...

Recommendation: Breast Cancer: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of supplemental screening for breast ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16395702/

Use of hormone therapy and risk of breast cancer detected ...

The population attributable fraction of breast cancer due to HT use was 19.8% overall. Ever users of HT tended to develop a cancer of lower grade. No other ...

HRT and Breast Cancer Risk Explained | BCRF

A 2021 review of systemic HRT in women with a history of breast cancer found that HRT significantly increased the risk of breast cancer recurrence, especially ...

Hormone Therapy and Breast Cancer Incidence Data

This aggregate dataset includes frequencies and adjusted quarterly rates of postmenopausal hormone therapy use and breast cancer.