Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- pCR
研究概览
简要总结
This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.
详细描述
Explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in high risk early, locally advanced and Inflammatory breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Primary invasive breast cancer confirmed by pathology; Before neoadjuvant therapy, the primary breast lesion was larger than 2cm(cT2-T4a-d, according to the anatomical staging of AJCC 8th edition), or the clinical images of lymph nodes considered metastasis or pathologically confirmed metastasis (CN+); or patients whose primary breast lesions are more than 1cm and less than 2cm, and whose lymph nodes have not metastasized (cT1cN0) must meet one of the following conditions: hormone receptor negative, HER2 positive, or ki67 greater than 20%. If bilateral breast cancer is found at the same time, it can be admitted to the group, but it is necessary to determine which side of the lesion is to be evaluated before taking the drug;
- •According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;
- •The score of ECOG is 0 or 1;
- •During neoadjuvant therapy, ovarian function suppression can be given at the same time;
- •The hematological examination and blood biochemical examination should meet the following requirements: white blood cell count (WBC)≥3.0×109/L, neutrophil count (ANC)≥1.5×109/L and platelet count (PLT) ≥ 75× 109/L; Hemoglobin (HB) ≥ 80g/L; Total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN), AST(sGOT), ALT(sGPT)≤2×ULN and creatinine (Cr) ≤ 1.5× ULN;
- •creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);
- •Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.
排除标准
- •Patients during pregnancy and lactation, patients with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;
- •There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;
- •There is evidence of sensory or motor nerve diseases;
- •Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;
- •allergic to the research drug or its auxiliary materials;
- •Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of the study;
- •Previous history of other malignant tumors, except the cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and the second primary malignant tumor with high 5-year recurrence-free survival rate determined by researchers;
- •According to the researcher's judgment, there are accompanying diseases (including but not limited to uncontrollable hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study, and any other circumstances that the researcher judges that the patient is not suitable for participating in this study.
研究组 & 干预措施
HER2 negative breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) negative breast cancer utidelone and cisplatin
干预措施: utidelone (Drug)
HER2 negative breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) negative breast cancer utidelone and cisplatin
干预措施: Cisplatin (Drug)
HER2 positive breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone，cisplatin，tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used)
干预措施: utidelone (Drug)
HER2 positive breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone，cisplatin，tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used)
干预措施: Cisplatin (Drug)
HER2 positive breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone，cisplatin，tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used)
干预措施: Trastuzumab (Drug)
HER2 positive breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone，cisplatin，tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used)
干预措施: Pertuzumab (Drug)
结局指标
主要结局
pCR
时间窗: through surgery completion, an average of 16 weeks
ypT0/is ypN0
次要结局
- RCB 0/I rate(through surgery completion, an average of 16 weeks)
- breast pCR(through surgery completion, an average of 16 weeks)
- RCB class(through surgery completion, an average of 16 weeks)
- EFS(2year,3year,5year,8year,10year)
- Safety(Through study completion，an average of 1 year)
- ORR by physical examination(After completing neoadjuvant therapy before surgery, an average of 16 weeks)
- ORR by MRI(After completing neoadjuvant therapy before surgery, an average of 16 weeks)
- Rate of lymph node negative(through surgery completion, an average of 16 weeks)
- DDFS(2year,3year,5year,8year,10year)
- OS(2year,3year,5year,8year,10year)
- CBR by physical examination(After completing neoadjuvant therapy before surgery, an average of 16 weeks)
- CBR by MRI(After completing neoadjuvant therapy before surgery, an average of 16 weeks)
- iDFS(2year,3year,5year,8year,10year)
- Quality of Life(Through study completion，an average of 1 year)
- Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients(After completing neoadjuvant therapy before surgery, an average of 16 weeks)