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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin

Criteria

Inclusion Criteria:

• Performance status 0 or 1

• Clinically stage 2 or 3 with histologically proven lymph node involvement

• Tumor or lymph node greater than 1.5 cm

Exclusion Criteria:

• Pregnancy or lactation

• Prior chemotherapy or radiotherapy for any malignancy

• Documented history of cardiac disease contraindicating anthracyclines

• Currently active infection