Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-01 @ 4:29 PM
Study NCT ID:
NCT06996093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
Chemotherapy Omission in Hormone Receptor(HR)-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
Detailed Description:
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
In this study, patient eligible will be randomized into either standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy or standard endocrine therapy plus CDK4/6 inhibitor following 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy.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 and patient reported outcome (PRO).
In this study, patient eligible will be randomized into either standard endocrine therapy plus CDK4/6 inhibitor without chemotherapy or standard endocrine therapy plus CDK4/6 inhibitor following 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy.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 and patient reported outcome (PRO).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: