A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Abraxane Combined With Epirubicin as Neoadjuvant Chemotherapy in Early Operable Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- ORR(CR+PR)
研究概览
简要总结
Some studies have demonstrated the efficacy of Abraxane in treating breast cancer in both adjuvant and metastatic settings. Few data is available on Abraxane in neoadjuvant treatment for breast cancer.
The aim of this project is to evaluate tailored primary systemic therapy with weekly Abraxane (125mg/m2) Combined With Q3week Epirubicin (100mg/m2) in early operable (stage of T2-4N0-3M0) breast cancer. This study will be an open label non randomized, single arm, single center study.
详细描述
The hypothesis is that tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is feasible and achieves high response rates.
It is proposed that 50 patients will be enrolled in this study. The target population is women with early breast cancer (stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
The primary objective of the trial is to determine the overall response rate. Secondary endpoints will include response rates in axillary lymph nodes, safety and tolerability and the rate of breast conservation.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Women and men at least 18 years of age or older.
- •Pathological confirmation of breast cancer
- •Tumor stage(TNM): T2-4N0-3M0
- •No evidence of distant metastasis
- •Adequate bone marrow, hepatic, and renal function
- •Measurable disease as per RECIST criteria
- •Karnofsky≥70
- •Laboratory criteria:
- •PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2*ULN
排除标准
- •Presence of metastatic disease.
- •Inflammatory breast cancer.
- •Bilateral breast cancer.
- •previous chemotherapy or hormonal therapy for current breast neoplasm.
- •other malignant tumors (concurrent or previous).
- •Pregnant woman.
- •Hypersensitive to any drug in Abraxane or Epirubicin regimen or any ingredient of Abraxane or Epirubicin.
- •Any severe systemic disease contraindicating chemotherapy.
研究组 & 干预措施
Abraxane Combined With Epirubicin
Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
干预措施: Abraxane (Drug)
Abraxane Combined With Epirubicin
Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
干预措施: Epirubicin (Drug)
结局指标
主要结局
ORR(CR+PR)
时间窗: Following the completion of 12 weeks of neoadjuvant chemotherapy Treatment.
To evaluate the efficacy of concurrent Abraxane and Epirubicin as neoadjuvant regimen in terms of: ORR(CR+PR), downstaging rates in tumor size and axillary lymph node. Pathological Complete Response(pCR) defined by: defined as ypT0, ypN0 (the absence of residual invasive and in situ cancer on evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy).
次要结局
- Overall Survival(OS)(First Dose of Abraxane and Epirubicin up to 5 years.)
- Side Effects.(First Dose of Abraxane and Epirubicin up to 24 months.)
- Event Free Survival(DFS)(Time of Surgery up to 5 years)