NCT01660542

An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.

Conditions

• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy with Docetaxel	Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -\> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-08-08
• Last updated: 2016-11-01

Locations

1 site across 1 country: South Korea