A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).
Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.
详细描述
Study Groups If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.
If you are in Group 1, you will receive paclitaxel for 4 cycles. You also will be treated with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.
If you are in Group 2, you will receive eribulin for 4 cycles. You will also be treated with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC or FAC.
Each cycle is 21 days.
Study Drug Administration for Group 1 You will receive paclitaxel by vein over 1 hour on Days 1, 8, and 15 of each 21-day study cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Histologically confirmed primary invasive adenocarcinoma of the breast.
- •Clinical stage breast cancer T2-3, N0-3, M0
- •Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).
- •No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.
- •Karnofsky performance status (KPS) of 80 - 100
- •The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Baseline MUGA or echocardiogram scans with LVEF of > 50%.
- •Normal PTT and either INR or PT < 1.5 x ULN.
- •Men or women 18 years of age or older.
- •Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.
- •Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.
排除标准
- •Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
- •Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.
- •Absolute neutrophils count (ANC) < 1500/mm^3
- •Total bilirubin > 1.5 times the upper limit of normal (ULN)
- •AST or ALT > 2.5 times the upper limit of normal (ULN)
- •Platelets < 100,000/mm^
- •Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)
- •Evidence of metastatic breast cancer following a standard tumor staging work-up
- •Evidence of inflammatory breast cancer.
- •Evidence of any grade 2 sensory or motor neuropathy.
- •Known human immunodeficiency viral (HIV) infection
- •Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.
- •Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.
研究组 & 干预措施
Paclitaxel + FEC or FAC Group
ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Paclitaxel (Drug)
Paclitaxel + FEC or FAC Group
ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: 5-Fluorouracil (Drug)
Paclitaxel + FEC or FAC Group
ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Epirubicin (Drug)
Paclitaxel + FEC or FAC Group
ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Cyclophosphamide (Drug)
Paclitaxel + FEC or FAC Group
ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Doxorubicin (Drug)
Eribulin + FEC or FAC Group
ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Eribulin (Drug)
Eribulin + FEC or FAC Group
ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: 5-Fluorouracil (Drug)
Eribulin + FEC or FAC Group
ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Epirubicin (Drug)
Eribulin + FEC or FAC Group
ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Cyclophosphamide (Drug)
Eribulin + FEC or FAC Group
ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians.
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: 4 -6 weeks from last dose of FAC/FEC-regimen.
Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.
次要结局
- 5 Year Event Free Survival (EFS)(from start of treatment, up to 5 years)
- Overall Survival (OS)(from start of treatment, up to 5 years)