PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

Please note, this study is only available to request by PALLAS investigators.

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III
study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine
therapy for patients with HR+ / HER2- early breast cancer (EBC).

The purpose of the PALLAS study is to determine whether the addition of palbociclib to
adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2-
early breast cancer. Assessment of a variety of correlative analysis, including evaluation of
the effect of palbociclib in genomically defined tumor subgroups, is planned.

请注意，本研究仅接受PALLAS研究团队研究者的申请。
本研究为一项前瞻性、双臂、国际多中心、随机、开放标签的III期临床试验，针对激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2-）早期乳腺癌（EBC）患者，评估在标准辅助内分泌治疗基础上加用2年帕博西尼（palbociclib）的疗效。
PALLAS研究的核心目的为明确：针对HR+/HER2-早期乳腺癌患者，在辅助内分泌治疗方案中联合帕博西尼，相比单纯内分泌治疗能否改善患者预后。本研究同时计划开展多项相关性分析，包括评估帕博西尼在基因组特征定义的肿瘤亚组中的治疗效果。