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.
Female aged 18-70 years old;
Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable), clinical stage IIA-IIIA;
Definite reports on ER/PR/HER2 receptor showing all HER2 negative (HER2 is 0~1+ or 2+ but determined negative via fluorescence in situ hybridization (FISH) or chemiluminescent in situ hybridization (CISH) detected (no amplification) is defined as HER2 negative);
According to RECIST 1.1, there is at least one measurable objective focus, tumor size > 2cm;
HER2 is positive;
Metastasis at any location;
Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study;
Parallel
Epirubicin
Drugi.v. 90 mg/m2
Cyclophosphamid
Drugi.v. 600 mg/m2
Docetaxel
Drugi.v. 100 mg/m2
Paclitaxel
Drugi.v. 175 mg/m2
pathological complete response (pCR)
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
objective response rate (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
disease free survival (DFS)
Events including local relapse, distant metastasis, contralateral breast cancer, second primary cancer or death from any cause
breast-conserving rate (BCR)
The rate of patients who were performed breast-conserving surgery.
Number of participants with adverse events
(like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms) as a measure of safety
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Changxing People's Hospital
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry
Collaborator
Huizhou Municipal Central Hospital
Collaborator
