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Recruiting

NCT Number: NCT06383026

Individuals on Hormone Therapy Breast Cancer Screening Pilot

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.

Recruiting

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Chandler S Cortina, MD, MS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Individuals on Hormone Therapy:

  • Males 40-75 years of age with a history of ≥9 months of estrogen and/or progesterone hormone therapy.
  • Females 40-75 years of age with any history of testosterone hormone therapy, with or without cosmetic mastectomy, but have not undergone complete mastectomy.
  • Persons who have undergone breast cancer screening before can participate.
  • 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.
  • Ability to speak, read, and write in English.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion criteria

for Breast Radiology Faculty:

  • 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).
  • Part of the breast radiology faculty who read both ABUS and MMG of the study participants.
  • Ability to speak, read, and write in English.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion criteria

for Breast Radiology Staff:

  • 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).
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Ability to speak, read, and write in English.

Exclusion criteria

for Individuals on Hormone Therapy

  • Females who have undergone or planned to undergo a complete mastectomy.
  • Females who are post-menopausal on estrogen +/- progesterone hormone therapy since it is a well-established risk for breast cancer).
  • 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

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

Exclusion for Breast Radiology Staff

  • Does not work with the breast radiology team.

Treatment and study plan

Breast Cancer Screening

Diagnostic Test

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

Survey/Interview

Other

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

Focus Group

Other

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 outcomes

  1. Callback and Biopsy Rates after Breast Cancer Screening

    Time frame: 3.5 years

    Determine the callback and biopsy rates after screening imaging of the entire individuals on hormone therapy patient cohort who complete breast imaging exams.

  2. Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy

    Time frame: 3.5 years

    Qualitative data utilized to identify themes around health beliefs, anxiety, and the breast cancer screening experience by describing the physical, cognitive, and emotional experience (perceived seriousness, perceived susceptibility, and anxiety) of individuals on hormone therapy cohort participants who complete surveys or participate in one-on-one interviews.

  3. Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening

    Time frame: 3.5 years

    Qualitative date utilized to identify individual and healthcare systems-level barriers to breast cancer screening for individuals on hormone therapy who complete surveys and/or participate in one-on-one interviews and breast imaging faculty and staff who participate in focus groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Chandler S Cortina, MD, MS

CONTACT

[email protected]

4149551453

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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