Clinical trial · Interventional
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
NCT07441486CI-TRIAL-00104354not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entinostat | Drug | — | UNRESOLVED |
| Oral Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: Entinostat
- Drug: Oral Paclitaxel
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Up to 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.