Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
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
Second Affiliated Hospital, School of Medicine, Zhejiang University
260 participants
Sep 20, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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.
Interventions
i.v. 90 mg/m2
i.v. 600 mg/m2
i.v. 100 mg/m2
i.v. 175 mg/m2
Locations(1)
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NCT04576143