Breast CancerNCT06383026
Individuals on Hormone Therapy Breast Cancer Screening Pilot
An observational study of Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Cancer Screening, Survey/Interview and Focus Group
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals on hormone therapy and breast cancer radiology stakeholders.
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
- 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.
- 1. Does not work with the breast radiology team.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Chandler S Cortina, MD, MS, ccortina@mcw..edu
About this study
Official title: Understanding Breast Cancer Risk and Screening in Individuals on Hormone Therapy Through a Pilot Breast Cancer Screening Program
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
- Being tested
- Breast Cancer Screening, Survey/Interview, Focus Group
- Keywords
- Mammogram, Mammography, Breast Cancer Screening, Breast Ultrasound, Breast Ultrasonography, Individuals on Hormone Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer ScreeningDiagnostic test
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
Survey/InterviewOther
A mixed-methods approach including electronic surveys and one on one interviews.
Focus GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Breast Cancer Screening; Other: Survey/Interview | |
| 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. Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Callback and Biopsy Rates after Breast Cancer Screening
Determine the callback and biopsy rates after screening imaging of the entire individuals on hormone therapy patient cohort who complete breast imaging exams.
Measured: 3.5 years
Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy
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.
Measured: 3.5 years
Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening
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.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start17 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
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
- Prospective
- Enrolment
- 130 participants (estimated)
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, MD, MS, Principal investigator, The Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383026
- Sponsor's protocol ID
- PRO00047199
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2024
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Breast Cancer Risk and Screening in Individuals on Hormone Therapy Through a Pilot Breast Cancer Screening Program
- ClinicalTrials.gov ID
- NCT06383026
- Acronym / sponsor ID
- PRO00047199
- Conditions
- Breast Cancer
- Keywords
- Mammogram, Mammography, Breast Cancer Screening, Breast Ultrasound, Breast Ultrasonography, Individuals on Hormone Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals on Hormone Therapy | – | Diagnostic Test: Breast Cancer Screening, Other: Survey/InterviewBreast 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 | – | Other: Focus GroupA 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals on hormone therapy and breast cancer radiology stakeholders.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Not a board-certified radiologist.
- Does not specialize in breast imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Cancer ScreeningScreening mammography as well as whole breast ultrasound interpreted by BI-RADS. | Diagnostic test | Individuals on Hormone Therapy |
| Survey/InterviewA mixed-methods approach including electronic surveys and one on one interviews. | Other | Individuals on Hormone Therapy |
| Focus GroupA 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. | Other | Breast Imaging Stakeholders |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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.
Chandler S Cortina, MD, MS principal investigator
The Medical College of Wisconsin
1 site 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, run by Medical College of Wisconsin at 1 site 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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chandler S Cortina, MD, MS (4149551453, ccortina@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Callback and Biopsy Rates after Breast Cancer Screening (time frame: 3.5 years). The study lists 3 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 30 Oct 2026.