NCT05251766Unknown1 期
Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
Xuli Meng0 个研究点目标入组 30 人开始时间: 2022年4月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- pathologic complete response (pCR) rate
研究概览
简要总结
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer
详细描述
- To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; 2. To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with human epidermal growth factor receptor 2(HER2)-negative breast cancer.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with age range ≥ 18 years;
- •a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
- •HER2 negative breast cancer, tumor >2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
- •Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]), known Ki67 value;
- •Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
- •patients have not previously had breast cancer treatment.
- •During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
- •Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable);
- •Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet（PLT）≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase（ALT） ≤ 3 times of the upper limit of normal).
排除标准
- •bilateral invasive breast cancer, metastatic disease or other malignant tumors.
- •Surgical axillary staging surgery was performed within 6 months before entering the study;
- •Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
- •before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
- •Patients with central nervous system metastasis or > grade 1 peripheral neuropathy;
- •Patients with severe myelosuppression at the time of screening;
- •Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
- •Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.);
- •Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
- •Patients with mental disorders;
- •Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration);
- •Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.
研究组 & 干预措施
Arm1: epirubicin + cyclophosphamide followed by docetaxel
Active Comparator
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles
干预措施: Docetaxel (Drug)
Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel
Experimental
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles
干预措施: Nab paclitaxel (Drug)
Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide
Experimental
Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles
干预措施: Nab paclitaxel (Drug)
结局指标
主要结局
pathologic complete response (pCR) rate
时间窗: 21 weeks
Proportion of PCR patients in enrolled breast cancer patients
次要结局
- Total clinical response rate(21 weeks)
研究者
Xuli Meng
chief physician
Zhejiang Provincial People's Hospital
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