HER2-negative Breast Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 260 |
Est. completion date | September 20, 2027 |
Est. primary completion date | June 20, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | 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 |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pathological complete response (pCR) | pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy. | Following the completion of 16 weeks or 24 weeks of neoadjuvant chemotherapy Treatment. | |
Secondary | objective response rate (ORR) | ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). | Following the completion of 16 weeks or 24 weeks of neoadjuvant chemotherapy Treatment. | |
Secondary | disease free survival (DFS) | Events including local relapse, distant metastasis, contralateral breast cancer, second primary cancer or death from any cause | Time of Surgery up to 5 years | |
Secondary | breast-conserving rate (BCR) | The rate of patients who were performed breast-conserving surgery. | Following the completion of 16 weeks or 24 weeks of neoadjuvant chemotherapy Treatment. | |
Secondary | Number of participants with adverse events | (like cardiotoxicity ,hematological toxicity,gastrointestinal symptoms) as a measure of safety | First Dose of chemotherapy up to 12 months. |
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