Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Drug: FEC3-D3
- Registration Number
- NCT02001506
- Lead Sponsor
- Asan Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 250
- 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
- Pregnancy or lactation
- Prior chemotherapy or radiotherapy for any malignancy
- Documented history of cardiac disease contraindicating anthracyclines
- Currently active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FEC3-D3 FEC3-D3 3 cycles of FEC followed by 3 cycles of Docetaxel 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
- Primary Outcome Measures
Name Time Method pathologic complete response (pCR) between two arms within the first 30 days (plus or minus 3 days) after surgery
- Secondary Outcome Measures
Name Time Method 3 year-disease free survival between two arms 3 year after surgery 1. Correlation of pCR and Ki-67 expression at baseline and D14 tumor specimen
2. 3 year-disease free survival
3. Correlation of pCR and biomarkers such as Ki-67 expression
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of