Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat HER2-negative breast cancer before surgery, using a method called dose-dense chemotherapy. This approach gives chemotherapy drugs more frequently, which may help some patients, especially those with cancer that has spread to their lymph nodes. The trial will compare this new treatment plan, which includes drugs like epirubicin and paclitaxel, with a standard chemotherapy regimen to see which is more effective and safe for women with this type of breast cancer.

To be eligible for the trial, participants must be women aged 18 to 70 who have been diagnosed with a specific stage of breast cancer (stage IIA-IIIA) and have tumors larger than 2 cm. They should also have a confirmed HER2-negative status and meet certain health criteria. Women who join the study will receive the assigned chemotherapy regimen and will be monitored closely for any side effects or benefits from the treatment. It's essential for potential participants to understand that they need to provide informed consent and may be excluded if they have certain health issues or have received previous cancer treatments.

Gender

FEMALE

Eligibility 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.