NCT01625429Unknown2 期
A Single-center, Prospective, Phase II Study of Albumin-bound Paclitaxel (Nab-paclitaxel) and Carboplatin With or Without Trastuzumab (Herceptin) as Neoadjuvant Therapy in Locally Advanced Breast Cancer
Shanghai Cancer Hospital, China1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, between 18 and 70 years old
- •Life expectancy is more than 12 months
- •Breast MRI or ultrasound confirmd tumor over 3cm and biopsy comfirned invasive breast caner of stage II-III (inflammatory breast cancer excluded)
- •Not accompanied with other malignancies（except for controlled carcinoma in situ of the cervix or skin basal-cell carcinoma）
- •A normal bone marrow: absolute neutrophil count≥1.5*10E9/L, hemoglobin≥100g/L, PLT≥100*10E9/L
- •Normal liver and renal functions: AST≤60U/L, total biliruin≤1.5*upper limit of normal, serum creatinine≤110umol/L, urea nitrogen≤7.1mmol/L
- •Normal blood coagulation function
- •ECOG performance status of 0-1
- •Willing to coordinate with a punch biopsy before treatment and accept neoadjuvant therapy
- •Women of child-producing potential must agree to use effective contraceptive methods during the study, and a negative serum or urine pregnancy test must be obtained within 7 days prior to administration of the drugs
- •Written informed consent
- •For HER-2 positive patients, the HER-2 status must be determined by ICH +++ or FISH/CISH. For patients treated with trastuzumb, LVEF≥55% by ultrasonic cardiogram or MUGA scan
排除标准
- •Previous systematic or local therapy including chemotherapy for breast cancer
- •Distant metastases of breast cancer are observed
- •Concurrent uncontrolled lung disease, severe sepsis, active peptic ulcer requring treatment, blood coagulation disorders, serious uncontrolled diabetes, connective tissue disease or bone marrow depression, unable to tolerate neoadjuvant therapy and related treatment
- •>Grade 1 peripheral neuropathy caused by any reason
- •History of CHF, uncontrolled symptomatic angina, history of arrhythmias or myocardial infarction, poorly controlled hypertension (systolic pressure > 180mmHg or diastlic pressure > 100 mmHg)
- •Lactational or gestational breast cancer
- •Not willing to accept a punch biopsy before treatment and neoadjuvant therapy
- •Psychopath or any other reasons that would preclude compliane with treatment
- •Known serious allergy to any of the study drugs or excipients
- •Participation in another study requiring administration of an in investigational drug or biological agent at present or recently (within the last 30 days prior to screening visit)
研究组 & 干预措施
neoadjuvant
Experimental
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: Obtained within six months of the last patient's enrollment
The percentage of patients with a pathological complete response after neoadjuvant therapy
次要结局
- Overall response rate(Obtained within six months of the last patient's enrollment)
- Three-year disease free survival(Obtained within 42 months after last patient's enrollment)
- Overall survival(Obtained around 5 years after the last patient's erollment)
- Safety(Obtained around six months after the last patient's enrollment)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal CancerLocally Advanced Rectal CancerNCT06760520The First Affiliated Hospital of Zhengzhou University40
尚未招募
2 期
IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)Esophageal Squamous Cell Carcinoma (ESCC)PD-1 InhibitorsNCT06078657The First Affiliated Hospital of Zhengzhou University46
招募中
2 期
A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based ChemotherapyOvarian CancerNCT05585281Yongpeng Wang25
Unknown
2 期
Trial of Surufatinib Combined With Toripalimab in the Treatment of Peritoneal Metastatic Carcinoma of Gastrointestinal or Primary Peritoneal CancerRefractory Metastatic Digestive System CarcinomaPrimary Peritoneal CancerNCT05030246Peking University72
尚未招募
2 期
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCCHead and Neck Squamous Cell CarcinomaNeoadjuvant TherapyNCT05993858Wuhan Union Hospital, China33