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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin; Paclitaxel

Criteria

Inclusion Criteria:

1. Female aged 18-70 years old;

2. Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable), clinical stage IIA-IIIA;

3. 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);

4. According to RECIST 1.1, there is at least one measurable objective focus, tumor size > 2cm;

5. Eastern Cooperative Oncology Group (ECOG) performance score is 0 or 1;

6. Cardiac function: left ventricular ejection fraction (LVEF)≥55%;

7. 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;

8. 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.

9. Informed consent form signed.

Exclusion Criteria:

1. HER2 is positive;

2. Metastasis at any location;

3. Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;

4. Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study;

5. Known allergic or intolerable to chemotherapeutic agents;

6. Previously suffering from malignant tumors within 5 years (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;

7. Cardiovascular disease: LVEF <50% (echocardiography) of New York Heart Association (NYHA) ≥ grade 2;

8. 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;

9. Already enrolled into other clinical trials;

10. The researchers judged the patients who were not suitable for this study.