Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Status:
Recruiting
Trial end date:
2027-09-20
Target enrollment:
Participant gender:
Summary
Recent clinical studies showed that breast cancer patients especially for those with lymph
node metastasis may benefit from dose-dense chemotherapy, like adriamycin and
cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd)
regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum
of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative
breast cancer patients. In our study, a prospective, randomized, open-label, multi-center
clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy
regimen (dd epirubicin/cyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional
chemotherapy (epirubicin/cyclophosphamide (EC) followed by docetaxel (T)) as preoperative
neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese
population.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators:
Changxing People's Hospital Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry Huizhou Municipal Central Hospital Women's Hospital School Of Medicine Zhejiang University Zhejiang Provincial People's Hospital