Cardinal Health (Shanghai) Pharmaceutical Co., Ltd.

Primary Objective To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improvement of IDFS in the study population. Secondary Objectives The secondary objectives of the study are: 1. To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on the following aspects in the study population: a. Overall survival (OS) b. Quality of life (QoL) c. Breast cancer free interval (BCFI) d. Distant metastasis free interval (DDFS) 2. To determine the safety and tolerability of adagloxad simolenin (OBI-822)/OBI-821 in the study population. Exploratory objectives The exploratory objectives are as follows: 1. To explore the correlation between adagloxad simolenin (OBI-822)/OBI-821 anti-Globo H antibody response, IDFS, and OS 2. To evaluate the impact of Globo H tumor expression on IDFS and OS 3. To identify patient baseline and demographic characteristics that may predict adagloxad simolenin (OBI-822)/OBI-821 treatment outcomes 4. To explore the correlation between baseline characteristics (including tumor pathology, molecular and immune characteristics) and tumor expression levels