Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Recruiting · NCT04576143 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance score is 0 or 1;
- Cardiac function: left ventricular ejection fraction (LVEF)≥55%;
- Normal bone marrow function: White blood cell count \> 4 × 10\^9/l, neutrophil count \> 1.5 × 10\^9/l, platelet count \> 100 × 10\^9/l and hemoglobin 9g/dl;
- Normal liver and renal function: aspartate aminotransferase (AST) and ALT ≤2.5 folds of the upper limit of normal values, total bilirubin ≤1.5 folds of the upper limit of normal values; Serum creatinine ≤1.5 folds of the upper limit of normal value.
- Informed consent form signed.
Exclusion criteria
- 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;
- Known allergic or intolerable to chemotherapeutic agents;
- Previously suffering from malignant tumors within 5 years (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
- Cardiovascular disease: LVEF \<50% (echocardiography) of New York Heart Association (NYHA) ≥ grade 2;
- Pregnant and breast-feeding women; Pregnancy test showed positive results before drug administration after enrolling in to the study; Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
- Already enrolled into other clinical trials;
- The researchers judged the patients who were not suitable for this study.
Where it is running
1 location listed.
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University - Hangzhou, Zhejiang, China