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Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Official title: Efficacy and Safety of Dose-dense Epirubicin and Cyclophosphamide Plus Paclitaxel as Neoadjuvant Chemotherapy for HER2-negative Early Breast Cancer:a Multicenter Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2020-09-20
Completion Date
2027-09-20
Last Updated
2021-08-12
Healthy Volunteers
No
Interventions
Epirubicin
i.v. 90 mg/m2
Cyclophosphamid
i.v. 600 mg/m2
Docetaxel
i.v. 100 mg/m2
Paclitaxel
i.v. 175 mg/m2
Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China