Recruiting

Breast Cancer Screening

Sponsor:

Medical College of Wisconsin

Code:

NCT06383026

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Breast Cancer Screening

Survey/Interview

Focus Group

Study Details

Brief summary:

This investigation is a prospective breast cancer screening study open to all individuals on hormone therapy. Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with hormone therapy and family cancer history and 2) investigate individuals on hormone therapy perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.

Conditions

Breast Cancer

Study ID

NCT06383026

Start date

Apr 17, 2024

Status verified date

Sep, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals on Hormone Therapy

Breast imaging data in the form of standard screening mammography in addition to screening whole breast ultrasound will be gathered and interpretations will follow the standard Breast Imaging Reporting and Data Systems.

Insight on the perceptions and experiences of being involved in a breast cancer screening program will be gathered.

Breast Imaging Stakeholders

A semi-structure focus group to explore radiology faculty and staff experiences while capturing information on the perceived screening barriers, what support and/or training staff require to ensure patients are treated equitable in the screening process, and areas for providers and healthcare systems to improve breast cancer screening for individuals on hormone therapy.

Interventions

Breast Cancer Screening

Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.

Survey/Interview

A mixed-methods approach including electronic surveys and one on one interviews.

Focus Group

A semi-structured focus group with open-ended questions that explores faculty and staff experiences in a breast cancer screening program for individuals on hormone therapy.

Primary outcome measure

  • Callback and Biopsy Rates after Breast Cancer Screening [ Time Frame: 3.5 years ]
  • Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy [ Time Frame: 3.5 years ]
  • Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening [ Time Frame: 3.5 years ]

Central Contacts and Locations

Central contacts

Chandler S Cortina, MD, MS

4149551453ccortina@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Chandler S Cortina, MD, MS

ccortina@mcw..edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

  • Mammogram
  • Mammography
  • Breast Cancer Screening
  • Breast Ultrasound
  • Breast Ultrasonography
  • Individuals on Hormone Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-09-23.