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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,508
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
invasive disease free survival
Invasive disease-free survival (IDFS), defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.
Time frame: 4 years
distant disease free survival
Distant disease free survival refers to the proportion of people alive and without distant metastases at a specified period after diagnosis, even if they had a local recurrence
Time frame: 4 years
overall survival
Overall survival (OS), defined as the time from the start of the study to the occurrence of death.
Time frame: 4 years
adverse effects
adverse effects graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Time frame: 4 years
patient reported outcome
Information about a patient's health that comes directly from the patient. Examples of patient-reported outcomes include a patient's description of their symptoms, their satisfaction with care, and how a disease or treatment affects their physical, mental, emotional, spiritual, and social well-being. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.
Time frame: 4 years
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