Spots Global Cancer Trial Database for Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

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Trial Identification

Brief Title: Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

Official Title: A Prospective, Randomized, Open-label, Multicenter Phase III Study to Explore Chemotherapy Omission in ER+/HER2-endocrine-sensitive Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

Study ID: NCT06341621

Conditions

Breast Cancer

Interventions

3-year abemaciclib without chemo

treatment of physician's choice

Study Description

Brief Summary: This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib

Detailed Description: This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib. In this study, patient eligible will be randomized into either endocrine drug plus 3-year adjuvant abemaciclib without chemotherapy or treatment of physician's choice (TPC).The safety and efficacy of each group will be assessed through invasive disease free survival (iDFS), disease-free survival (DFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.