Not yet recruiting NCT07441486
A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment of HR+HER2- Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Entinostat, Oral Paclitaxel.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Entinostat
Entinostat will be administered according to the study protocol. - Drug Oral Paclitaxel
Oral paclitaxel will be administered according to the study protocol.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Up to 24 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07441486 · E20250404