NCT05335473

Iribrine Plus Tucidinostat in the Treatment of HR+/HER2 Advanced Breast Cancer After CDK4/6 Inhibitor Failure

Phase I b/ II Clinical Study of Iribrine Mesylate Plus Tucidinostat in the Treatment of HR+/HER2- Locally Relapsed or Metastatic Breast Cancer After Previous CDK4/6 Inhibitor Failure

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer

Detailed description

To explore the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of the regimen of Eribulin plus Tucidinostat , and to initially explore the safety and efficacy of Eribulin plus Tucidinostat amine in patients with HR+/ HER2-advanced metastatic breast cancer

Conditions

• HR Positive HER2 Negative Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin and Tucidinostat	phase 1b： 3+3 trial design will be used for Tucidinostat dose escalation cohorts phase 2: Eribulin+Tucidinostat

Timeline

• Start date: 2022-05-13
• Primary completion: 2025-05-01
• Completion: 2025-11-01
• First posted: 2022-04-19
• Last updated: 2023-04-06

Locations

1 site across 1 country: China