A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Oral Paclitaxel (DHP107) Compared to IV Paclitaxel as First-line Therapy in Patients with Recurrent or Metastatic HER2 Negative Breast Cancer

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517090-24-00

Enrollment

Registered

2024-10-18

Start date

2020-10-09

Completion date

Unknown

Last updated

2026-01-13

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

Conditions

Recurrent or Metastatic HER2 Negative Breast Cancer

Brief summary

Progression-free survival (PFS)

Detailed description

Objective Response Rate (ORR), Overall survival (OS), Time to treatment failure (TTF), Disease Control Rate (DCR), EQ-5D-3L

Interventions

DRUGTAXOL 6 mg/ml

DRUGconcentrato per soluzione per infusione

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Objective Response Rate (ORR), Overall survival (OS), Time to treatment failure (TTF), Disease Control Rate (DCR), EQ-5D-3L	—

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Countries

Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026