A Study on the Association Between Alpha-2-glycoprotein 1, zinc-binding and Immune Checkpoint Inhibitor Resistance in Breast Cancer

Association Between Alpha-2-glycoprotein 1 (ZAG) Expression and Therapeutic Response in Triple-negative Breast Cancer Patients Treated with Immune Checkpoint Inhibitors - ZAG Expression and ICI Response in TNBC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058603

Enrollment

110

Registered

2025-07-25

Start date

2025-09-01

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed triple-negative breast cancer (TNBC), clinical stage II or III Received neoadjuvant chemotherapy including the immune checkpoint inhibitor according to the Keynote-522 regimen: four cycles of paclitaxel plus carboplatin plus pembrolizumab, followed by four cycles of epirubicin plus cyclophosphamide plus pembrolizumab Availability of pre-treatment core needle biopsy specimen preserved as FFPE tissue Underwent curative-intent breast surgery, with pathological evaluation of treatment response (pCR) feasible Informed consent obtained for retrospective research, or eligible under opt-out policy

Exclusion criteria

Exclusion criteria: Patients with a history or presence of malignancies other than breast cancer Patients whose pre-treatment biopsy specimens are not properly preserved as FFPE tissue Cases in which pathological response after surgery cannot be evaluated Cases in which treatment was initiated outside the designated study period Cases with incomplete clinical records or pathological information that preclude required analyses

Design outcomes

Primary

Measure	Time frame
To evaluate the association between pre-treatment ZAG expression level (measured by H-score in IHC) and pathological complete response (pCR; ypT0/isN0 or ypT0N0) in triple-negative breast cancer (TNBC) patients treated with ICI-based neoadjuvant chemotherapy (Keynote-522 regimen).	—

Secondary

Measure	Time frame
Association between ZAG expression and tumor-infiltrating lymphocyte (TIL) density Association between ZAG expression and PD-L1 expression (combined positive score using 22C3 antibody) Association between ZAG expression and HLA class I expression (H-score using EMR8-5 antibody) Association between ZAG expression and CD8+ T-cell localization patterns (Inflamed / Excluded / Desert)	—

Countries

Japan

Contacts

Public ContactToru Hanamura

Tokai University Department of Breast Oncology

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

Outcome results