To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+/HER2- breast cancer
o explore the efficacy and safety of Chidamide combined with endocrine drug maintenance after first-line chemotherapy in the treatment of advanced untreated breast cancer; To explore the efficacy and safety of Chidamidecombined with endocrine drugs after first-line chemotherapy in the treatment of advanced first-line non-chemotherapeutic breast cancer after failure of CDK4/6 inhibitors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Chidamide+ exemestane/Fulvestrant/Letrozole/Anastrozole/Tamoxifen
天津市肿瘤医院
Tianjin, China
RECRUITINGProgression-free survival
PFS is defined as the time from the date of treatment to the first date of disease
Time frame: 2 year
Objective response rate
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Time frame: 2 year
Disease control rate
his means that in all patients with a tumor who receive a certain treatment, the tumor shrinks or stays stable, and stays that way for a certain amount of time
Time frame: 2 year
Clinical Benefit Rate (CBR)
CBR is defined as the rate of patients who achieved complete response, partial response, and stable disease for \>= 24 weeks as the best response of treatment.
Time frame: 2 year
Overall Survival (OS)
OS defined as the time from the first study treatment administration to death from any cause
Time frame: 2 year
Adverse events (AE)
The level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0).
Time frame: 2 year
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