NEO-ADIXERN (NEO-ADjuvant IXabepilone in Breast Cancer). A Feasibility Study of Dose-dense FEC With G-CSF Support Followed by Dose-dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 15
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF.
To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.
详细描述
Estrogen receptor negative breast cancer may be defined as distinct biologic subtype disease, more aggressive with a typical molecular portrait. [30] This subtype seems to have a poor prognosis and poor treatment options because these patients are not candidate to hormonal therapy. Novel treatment strategies focusing upon this subtype are necessary in the future. [31] There are reports of clinical benefit in estrogen receptor negative patients treated with dose-dense chemotherapy (see background CALGB 9741 and MIG-1 study). In the CALGB 9741 study, patients randomized to receive dose-dense regimens experienced severe toxicities during paclitaxel treatment leading to dose reduction in 7% and 5%respectively.
Ixabepilone has shown consistent activity and an acceptable safety profile in patients with all stages breast cancer. This phase II study evaluate the feasibility of dose-dense Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as neo-adjuvant treatment for ER-negative breast cancer patients.
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
- •Histological documented diagnosis of breast cancer by incisional biopsy
- •Clinical T>=2
- •Females age >= 18 and <= 70 years
- •ECOG performance status 0-1
- •No prior treatment for breast cancer excluding therapy for DCIS
- •Subjects with hormone replacement therapy are eligible if this therapy is discontinued at least 2 weeks before starting therapy
- •Neutrophils > 2x109/L, Hgb > 9 g/dL, platelets > 100x109/L
- •Total bilirubin < 1 time the upper limit of normal (ULN) of the Institutional normal values and AST and/or ALT < 2.5 ULN, alkaline phosphatase < 2.5 ULN
- •Serum creatinine < 1.5 times the upper limit of normal (ULN)
- •Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or Echocardiography with EF only in HER-2 positive patients)
- •Negative pregnancy test prior to inclusion in the study (if potentially childbearing)
- •Signed Informed consent
排除标准
- •Prior or current history of ipsilateral or controlateral breast invasive cancer. A past or current history of ipsilateral ductal carcinoma in situ or ipsilateral/controlateral lobular neoplasia in situ are not an exclusion criteria as well as a controlateral ductal carcinoma in situ removed by mastectomy
- •Inflammatory breast cancer
- •Metastatic breast cancer (M1)
- •Histology other than adenocarcinoma of the breast
- •Male patients
- •Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
- •Patients unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational drug
- •History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
- •Symptomatic peripheral neuropathy > grade 1 according to the NCI CTC
- •Other serious illness or medical condition:
- •Congestive hearth failure or angina pectoris even if it is medically controlled. In particular, Ejection Fraction (EF) below the Institutional normal value for MUGA Fraction (EF) below the Institutional normal value for MUGA, or below 50% for ECHO
- •Previous history of myocardial infarction uncontrolled, high-risk ipertension or arrhythmia
- •History of significant neurological or psychiatric disorders including dementia or seizures
- •Active infection, active peptic ulcer, unstable diabetes mellitus or contraindications for the use of steroids
- •History of previous or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry
- •Prior severe HSR to agents containing Cremophor EL
研究组 & 干预措施
ARM 1
FEC e Ixabepilone. A goal of 48 patients will be enrolled in this study by 16 Italian centres of the GIM (Gruppo Italiano Mammella) Group. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled in the study
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: one year
次要结局
- Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol(one year)