Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FEC3-D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FEC3-D3
- description
- 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
- interventionNames
- Drug: FEC3-D3
- type
- NO_INTERVENTION
- label
- AC4-D4
- description
- 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
Primary outcomes (1)
- measure
- pathologic complete response (pCR) between two arms
- timeFrame
- within the first 30 days (plus or minus 3 days) after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHwang I, Kim JE, Jeong JH, Ahn JH, Jung KH, Son BH, Kim HH, Shin J, Lee HJ, Gong G, Kim SB. Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-shorter; NCT02001506). Breast Cancer Res Treat. 2023 Sep;201(2):193-204. doi: 10.1007/s10549-023-06971-7. Epub 2023 Jun 26. PMID 37365483