Hormone Receptor-Positive Male Breast CancerNCT07865507
Divergent Long-Term Clinical Courses in Two Men With Breast Cancer
An observational study of Hormone Receptor-Positive Male Breast Cancer, run by Azerbaijan Medical University at 1 site in Azerbaijan.
Trial summary
This observational study describes the long-term clinical courses of two men with hormone receptor-positive, HER2-negative invasive breast cancer. Although both tumors had similar receptor profiles, the patients experienced very different outcomes. Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Hormone Receptor-Positive Male Breast Cancer
- What is being tested?
- Follow-up
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 16 Nov 2016to 21 Aug 2026
- Phase
- Observational
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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: The study population consisted of two adult men with histologically confirmed hormone receptor-positive, HER2-negative invasive breast carcinoma treated within the same regional oncology network. Both cases had available pathology, imaging, treatment, and longitudinal follow-up data. The study retrospectively compared their clinicopathologic characteristics, treatment exposure, disease progression or recurrence status, and long-term clinical outcomesS
Inclusion Criteria: Sufficient clinical records available for review of pathology, treatment history, imaging, and longitudinal follow-up, Male patients aged 18 years or older; histologically confirmed invasive breast carcinoma; estrogen receptor-positive and progesterone receptor-positive disease, HER2-negative disease -
Exclusion Criteria: Female patients, patients younger than 18 years, breast lesions without histologic confirmation of invasive carcinoma, cases without adequate clinical documentation for longitudinal assessment
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Cases of Hormone Receptor-Positive, HER2-Negative Male Breast Cancer With Divergent Long-Term Clinical Courses
This observational study describes the long-term clinical courses of two men with hormone receptor-positive, HER2-negative invasive breast cancer. Although both tumors had similar receptor profiles, the patients experienced very different outcomes. One patient developed progressive locally advanced disease followed by metastases to the lungs, bones, liver, mediastinal lymph nodes, and bilateral axillary lymph nodes after multiple systemic treatments and without definitive breast surgery. The second patient underwent mastectomy and axillary surgery followed by adjuvant chemotherapy and had no documented locoregional recurrence approximately 9.6 years after surgery. The study compares clinical stage, lymph-node involvement, pathology, treatment exposure, imaging findings, and follow-up to illustrate that prognosis in male breast cancer cannot be determined from hormone receptor status or a single biomarker alone
Read the detailed description
This retrospective observational study describes two men with grade 2, estrogen receptor-positive, progesterone receptor-positive, HER2-negative invasive breast carcinoma who were treated within the same regional oncology network and had markedly different longitudinal clinical courses. The study examines clinicopathologic characteristics, local and systemic treatment, imaging, laboratory findings, and long-term outcomes.Case 1 had right-sided breast cancer initially documented as T2N0M0 in 2020 and presented to the National Oncology Center in 2023 with extensive involvement of the breast, nipple-areola complex, skin, and right axillary lymph nodes. Core biopsy showed invasive carcinoma of no special type, grade 2, with ER expression of approximately 90-95%, PR expression of 60-70%, HER2 immunohistochemistry 1+, and Ki-67 of approximately 10-12%. He received several systemic treatment regimens, including taxane- and anthracycline-based chemotherapy and later fulvestrant with ribociclib. Surgery was initially considered infeasible and was later offered after a clinical response but declined. The disease subsequently progressed, with pulmonary, osseous, hepatic, mediastinal, and bilateral axillary metastatic involvement documented during 2025-2026.Case 2 was diagnosed in 2016 with left-sided invasive breast carcinoma of no special type, grade 2. He underwent left mastectomy with axillary tissue removal. Six axillary lymph nodes contained metastatic carcinoma, with pathologic classification pT2N2aMx. The tumor showed ER expression of approximately 80%, PR expression of approximately 75%, HER2 immunohistochemistry 1+, and Ki-67 of approximately 30-35%. He received adjuvant anthracycline/cyclophosphamide-based chemotherapy followed by taxane treatment. At the latest documented assessment on 18 June 2026, approximately 9.6 years after surgery, there was no documented locoregional recurrence, no enlarged regional lymph nodes, no focal hepatic lesion, and serum CA 15-3 remained within the local reference range.The study focuses on the contrast between these two clinical courses despite broadly similar hormone receptor-positive, HER2-negative phenotypes. It evaluates the importance of anatomic stage, nodal burden, local disease control, treatment exposure and continuity, and serial clinical and imaging assessment. The comparison also illustrates that Ki-67, receptor status, or CA 15-3 should not be interpreted in isolation when assessing an individual patient's long-term course
- Being tested
- Follow-up
- Keywords
- male breast cancer; estrogen receptor (ER); progesterone receptor (PR); HER2-negative; invasive breast carcinoma; metastatic progression; long-term follow-up
- Medical subject headings
- Breast Neoplasms, Male, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Clinical treatments, diagnostic evaluations, imaging, pathology assessment, and follow-up were provided as part of routine clinical care and were not assigned by the observational study protocol. The study retrospectively reviewed these exposures and their associated longitudinal outcomes
| Study group | Role | What they receive |
|---|---|---|
| Case 1: Metastatic Right Breast Cancer | Male patient with grade 2, hormone receptor-positive, HER2-negative right breast carcinoma. The disease was initially documented as T2N0M0 in 2020 and later progressed to locally advanced and metastatic disease with pulmonary, osseous, hepatic, mediastinal, and bilateral axillary involvement. The patient received multiple systemic treatment regimens, but the cancer had progressed to incurable stage IV. Receives: Other: Follow-up | |
| Case 2: Long-Term Follow-up After Left Breast Cancer | Male patient with grade 2, hormone receptor-positive, HER2-negative left breast carcinoma who underwent mastectomy with axillary surgery in 2016, followed by adjuvant chemotherapy. At approximately 9.6 years after surgery, no documented locoregional recurrence, enlarged regional lymph nodes, or focal hepatic lesion was identified. Survival is about 10 years. Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Clinical Course of Male Breast Cance
Comparison of disease progression, recurrence status, metastatic spread, treatment exposure, and follow-up findings in two men with hormone receptor-positive, HER2-negative invasive breast carcinoma
Measured: From initial diagnosis through the latest documented follow-up, up to approximately 9.6 years
Longitudinal Clinical Course of Male Breast Cancer
Comparison of disease progression, recurrence status, metastatic spread, treatment exposure, and follow-up findings in two men with hormone receptor-positive, HER2-negative invasive breast carcinoma
Measured: From initial diagnosis through the latest documented follow-up, up to approximately 9.6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start16 Nov 2016
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hormone Receptor-Positive Male Breast CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azerbaijan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahira Amirova, Azerbaijan Medical University
- Investigators
- Mahira Firudin Amirova, PhD, Principal investigator, Azerbaijan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865507
- Sponsor's protocol ID
- NOC/EC-2026-01
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a two-patient retrospective case report containing detailed clinical, pathology, imaging, treatment, and longitudinal follow-up information. Given the very small sample size and the specificity of the clinical histories, participant re-identification remains possible even after removing direct identifiers.
Publications
Giordano SH. Breast Cancer in Men. N Engl J Med. 2018 Jun 14;378(24):2311-2320. doi: 10.1056/NEJMra1707939. No abstract available.
PubMed 29897847