A Single-center, Prospective, Single Arm Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin（PLD）Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pathological complete response(pCR) rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
详细描述
This is a single-center, prospective, single arm phase II study. Eligible patients will receive neoadjuvant therapy with pegylated liposome doxorubicin (PLD)/albumin-bound paclitaxel/trastuzumab regimentation.
This study consists of two phases, the first phase aims to determine the maximum tolerated dose (MTD) of PLD, and the second phase will explore the efficacy and safety of the regimen.
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
- •Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
- •Female patients aged from 18 to 70 years old;
- •Histologically confirmed as invasive breast cancer. occult breast cancer, inflammatory breast cancer and eczematoid carcinoma are ineligible;
- •Clinical stageⅡ-Ⅲ;
- •HER-2 Positive（defined by: IHC 3+ or ISH positive）;
- •Without previous treatment for this breast cancer;
- •Patients must have at least one measurable disease according to RECIST 1.1;
- •ECOG (Eastern Cooperative Oncology Group) performance score of 0-1 points;
- •Normal ECG;
- •Bone marrow function:absolute neutrophil count (ANC)≥2.0×109/L，platelets≥100×109/L，hemoglobin ≥90g/L。
- •Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤1.5×ULN，serum total bilirubin≤ ULN;
- •Renal function：serum creatinine≤1.5×ULN； Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.
排除标准
- •New York Heart Association (NYHA) class ≥Ⅱ heart failure.
- •Known or suspected hypersusceptibility to any agents used in the treatment protocol.
- •Need to Concurrent treatment with any other anti-cancer therapy considered by the investigator.
- •participating in other clinical trials within 4 weeks before this study.
- •Serious heart disease, including but not limited to:
- •Significant ventricular arrhythmia or high degree atrioventricular block (Mobitz II or third degree atrioventricular block); 2) unstable angina; 3) clinically significant heart valve disease; 4) Electrocardiogram shows transmural myocardial infarction; 5) Uncontrolled hypertension.
- •Uncontrolled diabetes.
- •Severe or uncontrolled infection.
- •Hepatitis b surface antigen positive, or hepatitis c virus antibody positive, or human immunodeficiency virus (HIV) antibody positive.
- •Active malignancy, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin，within the past 5 years.
- •9）Women who are pregnant , breastfeeding ,or refuse to use adequate contraception prior to study entry and for the duration of study participation.
- •10）Other conditions considered to be inappropriate to be enrolled by the investigator.
研究组 & 干预措施
PLD/albumin-bound paclitaxel/Trastuzumab
First phase
PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6.
Second phase
PLD: maximum tolerated dose (MTD). IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6.
干预措施: Pegylated Liposomal Doxorubicin (Drug)
PLD/albumin-bound paclitaxel/Trastuzumab
First phase
PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6.
Second phase
PLD: maximum tolerated dose (MTD). IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6.
干预措施: Albumin-bound paclitaxel (Drug)
PLD/albumin-bound paclitaxel/Trastuzumab
First phase
PLD: Level 1：30mg/m2； Level 2：35mg/m2； Level 3：40mg/m2； IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion , Subsequent infusions 6mg/kg. d1, q21d×6.
Second phase
PLD: maximum tolerated dose (MTD). IV, d1, q21d×6.
albumin-bound paclitaxel: 220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
Trastuzumab：8mg/kg IV for the first infusion ,Subsequent infusions 6mg/kg. d1, q21d×6.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Pathological complete response(pCR) rate
时间窗: 5 months
Percentage of patients who do not exhibit residual invasive breast cancer in breast and lymph nodes at time of surgery
次要结局
- Rate of Breast conserving surgery(5 months)
- Rate of surgery(5 months)
- adverse events(5 months)
研究者
Fei Ma
Principal Investigator
Peking Union Medical College