Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:
- trastuzumab (Herceptin)
- epirubicin (Ellence)
- cyclophosphamide (Cytoxan)
- docetaxel (Taxotere)
详细描述
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis.
Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant females =/> 18 years of age
- •Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
- •Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
- •Normal cardiac function and adequate hematologic function
- •Human epidermal growth factor receptor 2 protein (HER2) positive
- •No evidence of metastatic disease
- •ECOG Performance Status 0 - 1
- •Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
排除标准
- •Treated with other investigational drugs within 30 days
- •Uncontrolled intercurrent disease or active infection
- •Known sensitivity to e. coli-derived proteins or polysorbate 80
- •Psychiatric illness or social situation that would limit study compliance
- •Pre-existing peripheral neuropathy > Grade 1
- •Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
- •Bilateral synchronous breast cancer
- •Inflammatory breast cancer
- •Women who are pregnant or breast feeding
研究组 & 干预措施
Neoadjuvant therapy
Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
干预措施: epirubicin (Drug)
Neoadjuvant therapy
Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
干预措施: cyclophosphamide (Drug)
Neoadjuvant therapy
Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
干预措施: docetaxel (Drug)
Neoadjuvant therapy
Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
干预措施: trastuzumab (Drug)
结局指标
主要结局
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
时间窗: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with \> 85% of the protocol-specified dose.
Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
时间窗: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.
Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.
次要结局
- Pathologic Response(At completion of neoadjuvant treatment period, up to 24 weeks.)
- Clinical Response Prior to Surgery(Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.)
- Left Ventricular Ejection Fraction (LVEF)(At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36)
- Progression-free Survival (PFS)(PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.)
- Overall Survival (OS)(Measured from day 1 of treatment until time of death, assessed up to 48 months.)