Evaluating a new chemotherapy regimen for HER2-negative breast cancer before surgery
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
This study is testing a new type of chemotherapy to see if it works better than standard treatment for women with HER2-negative breast cancer before they have surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04576143 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a dose-dense chemotherapy regimen (ddEC-ddP) compared to conventional chemotherapy for patients with HER2-negative breast cancer. The study is a prospective, randomized, open-label, multi-center trial conducted in China, focusing on women aged 18-70 with specific eligibility criteria. It aims to determine the optimal chemotherapy approach for this population, particularly for those with lymph node metastasis, by assessing treatment outcomes before surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-70 with histologically confirmed HER2-negative unilateral invasive breast cancer at clinical stages IIA-IIIA.
Not a fit: Patients with HER2-positive breast cancer or those with distant metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and survival rates for patients with HER2-negative breast cancer.
How similar studies have performed: Previous studies have shown promising results with dose-dense chemotherapy regimens in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Yiding Chen — 2nd Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Yiding Chen
- Email: ydchen@zju.edu.cn
- Phone: 571-87784527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.