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
Overview
- Phase
- Phase 3
- Intervention
- FEC3-D3
- Conditions
- Breast Cancer
- Sponsor
- Asan Medical Center
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- pathologic complete response (pCR) between two arms
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Sung-Bae Kim
Professor
Asan Medical Center
Eligibility 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
Arms & Interventions
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
Intervention: FEC3-D3
Outcomes
Primary Outcomes
pathologic complete response (pCR) between two arms
Time Frame: within the first 30 days (plus or minus 3 days) after surgery
Secondary Outcomes
- 3 year-disease free survival between two arms(3 year after surgery)