A Real-world Study of Paclitaxel Injection (Albumin-bound) for Neoadjuvant Treatment of Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
Neoadjuvant chemotherapy is a systemic cytotoxic drug therapy for non-metastatic tumors before local therapy, Now it has become an important part of standard treatment for a stage II, III, and the first clinical Ⅳ breast cancer .Both domestic and foreign authoritative guidelines recommend the use of albumin-binding paclitaxel in the neoadjuvant treatment of breast cancer .In addition, clinical studies at home and abroad have preliminarily confirmed the application value and therapeutic benefit of albumin-binding paclitaxel in breast cancer neoadjuvant therapy, and the toxic and side effects can be tolerated.
详细描述
Data were collected on the efficacy and safety of neoadjuvant therapy in patients receiving albumin-binding taxol regimens,Subgroup analysis was performed for different treatment regimens, dosages, molecular subtypes and tumor stages,To further screen the dominant population and the chemotherapy regimen with clinical benefit of albumin paclitaxel, so as to provide evidence-based medical evidence for breast cancer neoadjuvant clinical diagnosis and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
- •target population 1)The histologic diagnosis of the primary invasive breast cancer and clinical stage I - III, first option Ⅳ period; 2) One of the following conditions:Large mass (>3cm);Axillary lymph node metastasis;her-2 positive; tri-negative; For those who are willing to preserve breast, but have difficulty in breast conserving due to the large proportion of tumor size and breast volume; 3) The clinician determined that the patient was suitable for the treatment with albumin-binding taxol regimen;4) The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study 5)No contraindications for nab-paclitaxel.
- •Age and reproductive status 1) Age ≥ 18 years 2) Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy; 3) Women must not lactate.
排除标准
- •Allergy to paclitaxel for injection (albumin binding) and/or its adjuvants has been demonstrated;
- •Pregnant or lactating women
- •Abnormal results of physical examination and laboratory examination 1) Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) < 90g/L 2) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) >2.5 × institutional upper limit of normal (ULN), >5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)>1.5 × ULN; 3) Creatinine (CRE)> 1.5 × ULN 4) Prothrombin time (PT) and international normalized ratio (INR) > 1.5 × ULN. Unless the subject had received anticoagulant treatment
- •Paclitaxel for injection (albumin binding type) contraindications in patients
- •Participating in clinical trials of other taxoids
- •Patients with concomitant other tumors, other than cured carcinoma in situ of the cervix and non-melanoma skin cancer
- •Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
- •The researchers considered that there were other conditions that were not suitable for enrollment.
研究组 & 干预措施
nab-paclitaxel
nab-paclitaxel monotherapy or combination therapeutic regimen
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 6 months
defined as the time from the beginning of randomization to recurrence or death due to disease progression
the Pathological complete remission(pCR)
时间窗: 2 weeks
Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.
次要结局
- the overall survival (OS)(6 months)
- Breast conserving rate(6 months)
研究者
Aiping shi
Chief physician and associate professor
Jilin University