NCT06835400

Oral Paclitaxel + Encequidar vs IV Paclitaxel in Treatment of HER2 Negative Metastatic Breast Cancer

An Open-Label, Randomized, Two-stage Study to Determine Dose Optimization, Safety, and Noninferiority of Oral Paclitaxel + Encequidar Compared to IV Paclitaxel in Subjects With HER2 Negative Metastatic Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Health Hope Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current study is being conducted to find an optimal Oral Paclitaxel + Encequidar dose and regimen based on prior experience with oral paclitaxel (stage 1) and to compare that dose to an accepted dose and regimen of intravenous (IV) paclitaxel in subjects with metastatic breast cancer (stage 2).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel Capsule	Paclitaxel Capsule
DRUG	IV Paclitaxel	IV Paclitaxel
DRUG	Encequidar tablet	Encequidar tablet

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-04-01
• Completion: 2029-05-01
• First posted: 2025-02-19
• Last updated: 2025-07-11

Regulatory

• FDA-regulated drug study