An observational study in Hormone Receptor-Positive Male Breast Cancer, sponsored by Azerbaijan Medical University. Completed at 1 site in Azerbaijan. Open to male participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Azerbaijan Medical University · Observational
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
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
123 studies on the registry are indexed under Breast Neoplasms, Male; 7 are open to participants now.
This study's enrollment of 2 is below the median of 150 across 13 observational studies indexed under Breast Neoplasms, Male.
Browse Breast Neoplasms, Male studies →Azerbaijan Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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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.
Other: Follow-up
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.
Other: Follow-up
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
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
Time frame: 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
Time frame: From initial diagnosis through the latest documented follow-up, up to approximately 9.6 year
Plan to share: 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.
Ran from Nov 2016 to primary completion in Aug 2026, 117 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Azerbaijan Medical University