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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107234
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HR positive HER2 negative advanced breast carcinoma

Interventions

Experimental group:Vinorelbine combined with entinostat

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. Patients with advanced breast carcinoma confirmed by histopathological and / or cytological examination; 3. HR positive HER2-negative breast carcinoma with confirmed primary and / or metastatic lesions; 4. There must be at least one evaluable tumor lesion (according to RECIST1.1); 5. Patients who have previously received 2-4 lines of treatment must include endocrine therapy combined with CDK4/6 inhibitors, chemotherapy containing paclitaxel as the first-line treatment, and ADC drugs as the first-line treatment, if applicable. 6. Comprehensive clinical data are available for important research indicators. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 8. Life expectancy > 6 months;

Exclusion criteria

Exclusion criteria: 1. Male with breast carcinoma; 2. Have other malignant neoplasms; 3. Patients with incomplete clinical case characteristics; 4. Previous or current metastatic disease of the central nervous system or leptomeninges; 5. Women during pregnancy and breastfeeding; 6. Other reasons have led the researcher to believe that the participant is not suitable for this study.

Design outcomes

Secondary

MeasureTime frame
Overall Survival, OS;Objective Response Rate, ORR;Disease Control Rate, DCR;Safety;

Primary

MeasureTime frame
progression-free survival, PFS;

Countries

China

Contacts

Public ContactChen Wang

Tianjin Medical University Cancer Institute and Hospital

oncology@vip.qq.com+86 18622221770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026