A Phase 3 interventional study of FEC3-D3 in Breast Cancer, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Asan Medical Center · Phase 3, Interventional, and Treatment
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.
To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 250 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: FEC3-D3
4 cycles of Adriamycin plus Cyclophosphamide (AC) followed by 4 cycles of Docetaxel Adriamycin 60 mg/m2, every 3 weeks Cyclophosphamide 600 mg/m2, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks
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
Also known as: 5-FU, Pharmorubicin, Cytoxan, Docetaxel
pathologic complete response (pCR) between two arms
Time frame: within the first 30 days (plus or minus 3 days) after surgery
3 year-disease free survival between two arms
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
Time frame: 3 year after surgery
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Asan Medical Center