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Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer

Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer - Elucidation of tumor immuno-regulatory mechanism via androgen receptor signal in breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040836
Enrollment
60
Registered
2020-08-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Sponsors

Tokai University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Those with a definitive diagnosis of breast cancer obtained by needle biopsy. 2) No previous history of breast cancer treatment (for metachronous bilateral breast cancer, history of initial breast cancer is acceptable). 3) Estrogen receptor (ER) positive (>1%) and HER2 negative (score 1 or score 2 DISH negative) 4) Those who received sufficient explanation for participation in this research and obtained their written consent by their free will.

Exclusion criteria

Exclusion criteria: 1) Age less than 20 years old. 2) Anyone or more of steroids, immunosuppressants, sex hormones, and endocrine therapeutics have been administered within the past 3 months. 3) Pathological conditions (primary immunodeficiency, HIV infection, hematological cancer (including past history)) that may be accompanied by abnormal systemic immune function. 4) Breast cancer diagnosed by incision biopsy. 5) Those with clear hematoma formation or infection after needle biopsy. 6) Those who received pre-operative drug therapy. 7) In case of insufficient tumor sample for routine pathological examination if sample are collectied for this study.

Design outcomes

Primary

MeasureTime frame
The correlation between ZAG, intratumoral immune cell composition, cytokine composition, expression of various immune checkpoint-related molecules, and TILs.

Secondary

MeasureTime frame
The action of recombinant ZAG on primary immune cells or model cell lines, corresponding to immune cells considered to be the primary target of ZAG.

Countries

Japan

Contacts

Public ContactToru Hanamura

Tokai University School of Medicine Department of Breast and Endocrine Surgery

hanamura.toru.w@tokai.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026