Tokyo, July 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058603) titled 'A Study on the Association Between Alpha-2-glycoprotein 1 and Immune Checkpoint Inhibitor Resistance in Breast Cancer' on July 25.

Study Type: Observational

Primary Sponsor: Institute - Tokai University

Condition: Condition - Breast Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study investigates the association between the expression of Alpha-2-glycoprotein 1 (ZAG) and therapeutic response in triple-negative breast cancer (TNBC) patients treated with immune checkpoint inhibitor (ICI)-based neoadjuvant chemotherapy (NAC). ZAG, secreted in an androgen receptor-dependent manner, has been reported to contribute to the formation of an immunosuppressive tumor microenvironment (TME), which may underlie ICI resistance. By retrospectively analyzing pre-treatment biopsy samples, we aim to clarify whether ZAG contributes to ICI resistance through immunosuppressive TME and to evaluate its potential as a predictive biomarker and therapeutic target. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 25 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2032 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067008

Disclaimer: Curated by HT Syndication.