Breast screening for people on hormone therapy

Understanding Breast Cancer Risk and Screening in Individuals on Hormone Therapy Through a Pilot Breast Cancer Screening Program

This pilot will see if combining mammography and breast ultrasound with surveys and interviews improves screening for people on hormone therapy aged mostly 40–75 (and some 30–39 with family history).

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 30 Years to 75 Years
• Sex: All
• Sponsor: Medical College of Wisconsin (Academic / other)
• Locations: 1 site (Milwaukee, Wisconsin)
• Trial ID: NCT06383026 on ClinicalTrials.gov

What this trial studies

This prospective mixed-methods pilot will collect quantitative breast imaging (mammography and ultrasound) alongside medication and family history information in people taking hormone therapy. Participants will also complete surveys and may join interviews or focus groups to capture perceptions and experiences with screening. The study aims to identify individual- and system-level barriers to timely screening and to compare imaging findings in the context of hormone exposures. Breast radiology faculty who read both automated breast ultrasound and mammography at the Medical College of Wisconsin will be involved in image interpretation.

Who should consider this trial

Good fit: Ideal candidates are people aged 40–75 on hormone therapy (males with ≥9 months of estrogen and/or progesterone, females with any history of testosterone) and select 30–39-year-olds with a first- or second-degree family history of breast cancer who can consent in English.

Not a fit: People not on hormone therapy, those who have had a complete mastectomy, or individuals who cannot participate in English or travel to the site are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, the project could lead to clearer, more tailored screening guidance and earlier detection for people on hormone therapy.

How similar studies have performed: Prior studies have shown hormone therapy can change breast density and affect imaging performance and some centers have trialed ultrasound as an adjunct, but comprehensive mixed-methods pilots focused specifically on people on hormone therapy remain limited.

Eligibility criteria

Inclusion Criteria for Individuals on Hormone Therapy:

1. Males 40-75 years of age with a history of ≥9 months of estrogen and/or progesterone hormone therapy.
2. Females 40-75 years of age with any history of testosterone hormone therapy, with or without cosmetic mastectomy, but have not undergone complete mastectomy.
3. Persons who have undergone breast cancer screening before can participate.
4. Individuals who meet criteria for above eligibility and are ≥30-39 years of age with a 1st or 2nd degree family member with breast cancer.
5. Ability to speak, read, and write in English.
6. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Breast Radiology Faculty:

1. Board-certified radiologist that specializes in breast imaging and are an actively employed faculty member at Froedtert \& the Medical College of Wisconsin (main campus location).
2. Part of the breast radiology faculty who read both ABUS and MMG of the study participants.
3. Ability to speak, read, and write in English.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Breast Radiology Staff:

1. Must be either a technician, nurse, or clerical staff that works with the breast radiology team at Froedtert \& the Medical College of Wisconsin (main campus location).
2. Ability to understand a written informed consent document, and the willingness to sign it.
3. Ability to speak, read, and write in English.

Exclusion Criteria for Individuals on Hormone Therapy

1. Females who have undergone or planned to undergo a complete mastectomy.
2. Females who are post-menopausal on estrogen +/- progesterone hormone therapy since it is a well-established risk for breast cancer).
3. A personal history of breast cancer or a known pathogenic gene mutation that increases the risk of breast cancer development (e.g., BRCA1/2, etc.) given that well-defined surveillance and screening recommendations exist for these persons.

Exclusion Criteria for Breast Radiology Faculty

1. Not a board-certified radiologist.
2. Does not specialize in breast imaging.
3. Does not read ABUS and MMG and/or has not read imaging for study participants.

Exclusion for Breast Radiology Staff

1\. Does not work with the breast radiology team.

Where this trial is running

Milwaukee, Wisconsin

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Chandler S Cortina, MD, MS — The Medical College of Wisconsin
• Study coordinator: Chandler S Cortina, MD, MS

Conditions Breast Cancer; Mammogram; Mammography; Breast Cancer Screening; Breast Ultrasound; Breast Ultrasonography; Individuals on Hormone Therapy