NCT02001506

Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

Detailed description

To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	FEC3-D3	Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-12-05
• Last updated: 2017-08-29

Locations

1 site across 1 country: South Korea