- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06133647
Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
March 24, 2026 updated by: Methodist Health System
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Male breast cancer (MBC) is a rare disease without sufficient clinical data supporting the management and treatment.
The treatment of MBC arises from data extrapolated from female breast cancer (FBC).
MBC has higher mortality than FBC.
Previous studies have suggested differences between MBC and FBC; however, treatments remain the same for both.
Larger studies in MBC are needed to provide more clinical data to help guide treatment.
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75203
- Clinical Research Institute at Methodist Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
- ≥ 18 years of age
- Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast
Description
Inclusion Criteria:
- • ≥ 18 years of age Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast
Exclusion Criteria:
18 years of age
- Prisoners
- Pregnant or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis Rates of patients with MBC and FBC
Time Frame: 13 years
|
complications of treatment
|
13 years
|
|
Recurrence rates of Patients with MBC and FBC
Time Frame: 13 years
|
Recurrence rates of Patients with MBC and FBC
|
13 years
|
|
Duration of remission in Patients with MBC and FBC
Time Frame: 13 years
|
Duration of remission in Patients with MBC and FBC
|
13 years
|
|
The Overall Survival of patients with MBC and FBC after receiving treatment
Time Frame: 13 years
|
The Overall Survival of patients with MBC and FBC after receiving treatment
|
13 years
|
|
Determine the complications of Treatment in patients with MBC and FBC
Time Frame: 13 years
|
Determine the complications of Treatment in patients with MBC and FBC
|
13 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2023
Primary Completion (Actual)
May 1, 2025
Study Completion (Actual)
May 1, 2025
Study Registration Dates
First Submitted
July 6, 2023
First Submitted That Met QC Criteria
November 13, 2023
First Posted (Actual)
November 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 24, 2026
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Breast Carcinoma In Situ
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Skin Diseases
- Breast Diseases
- Carcinoma
- Neoplasms, Ductal, Lobular, and Medullary
- Breast Neoplasms
- Carcinoma in Situ
- Skin and Connective Tissue Diseases
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Lobular
Other Study ID Numbers
- 015.MTP.2023.A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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