NCT01352494

Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Korean Breast Cancer Study Group · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.

Detailed description

Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.

Conditions

• Breast Cancer Stage II
• Breast Cancer Stage III

Interventions

Type	Name	Description
DRUG	docetaxel	docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles
DRUG	gemcitabine	gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-05-01
• Completion: 2015-05-01
• First posted: 2011-05-12
• Last updated: 2011-05-27

Locations

1 site across 1 country: South Korea