[Translation] GLORIA Study: A Phase III, Randomized, Open-Label Study of the Anti-Globo-H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in Patients with High-Risk Early-Globo H-Positive Triple-Negative Breast Cancer
主要目的
确定研究人群中adagloxad simolenin (OBI-822)/OBI-821治疗对IDFS改善的影响。
次要目的
研究的次要目的是:
1. 确定研究人群中adagloxad simolenin (OBI-822)/OBI-821治疗对以下方面的影响:
a. 总生存期(OS)
b. 生活质量(QoL)
c. 无乳腺癌间期(BCFI)
d. 无远处转移间期(DDFS)
2. 确定研究人群中adagloxad simolenin (OBI-822)/OBI-821的安全性和耐受性。
探索性目的
探索性目的如下:
1. 探索adagloxad simolenin (OBI-822)/OBI-821抗Globo H抗体应答、IDFS以及OS之间的相关性
2. 评价Globo H肿瘤表达对IDFS和OS的影响
3. 识别可预测adagloxad simolenin(OBI-822)/OBI-821治疗结局的患者基线特征和人口统计学特征
4. 探索基线特征(包括肿瘤病理、分子和免疫特征)和肿瘤表达水平之间的相关性
[Translation] main purpose
To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improvement in IDFS in the study population.
secondary purpose
The secondary aims of the study are:
1. To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on:
a. Overall survival (OS)
b. Quality of Life (QoL)
c. Breast cancer free interval (BCFI)
d. No distant metastasis interval (DDFS)
2. To determine the safety and tolerability of adagloxad simolenin (OBI-822)/OBI-821 in the study population.
exploratory purpose
Exploratory purposes 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 effect of Globo H tumor expression on IDFS and OS
3. Identify baseline and demographic characteristics of patients that predict outcomes from adagloxad simolenin (OBI-822)/OBI-821 treatment
4. Explore the correlation between baseline characteristics (including tumor pathology, molecular and immune characteristics) and tumor expression levels