Breast Cancer
Conditions
Brief summary
Objective: To explore the curative effect and safty of Changchun Ruibin metronomic chemotherapy combined with endistat in the treatment of HR positive HER2 negative advanced breast carcinoma.
Interventions
DRUGEntinostat
Entinostat will be administered according to the study protocol.
DRUGOral Paclitaxel
Oral paclitaxel will be administered according to the study protocol.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Only participants who meet all of the following eligibility criteria will be eligible for this trial: * Age ≥ 18 years; * Patients with advanced breast carcinoma confirmed by histopathological and / or cytological examination; * HER2-negative breast carcinoma with confirmed HR positive primary and / or metastatic lesions; * At least one evaluable tumor lesion (according to RECIST1.1); * Prior 2-4 lines of therapy, which must include one endocrine therapy with CDK4 / 6 inhibitors, one chemotherapy with paclitaxel. * Previous 1L of ADC drug therapy is acceptable. * Complete clinical data on important research indicators; * The Eastern Oncology Assistance Group (ECOG) physical fitness status score was 0-2; * Life expectancy \> 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 24 months | PFS is defined as the time from first dose to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. |
Outcome results
None listed