EUCTR2006-006494-24-BE进行中（未招募）不适用
Randomized, open label, multicentric phase III trial evaluating the benefit of a sequential regimen associating FEC100 and Ixabepilone in adjuvant treatment of non metastatic, poor prognosis breast cancer defined as triple-negative tumor (HER2 negative - ER negative - PR negative) or HER2 negative and PR negative tumor; in node positive or node negative patients. - TavIx
Fédération Nationale des Centres de Lutte Contre le Cancer0 个研究点目标入组 2,500 人开始时间: 2007年8月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1) Women aged from 18 to 70 years
- •2) Histologically proven invasive unilateral breast cancer (regardless of the type)
- •3) Initial clinical condition compatible with complete initial resection
- •4) No residual macro or microscopic tumor after surgical excision
- •5) Beginning of chemotherapeutic treatment no later than day 49 after the initial surgery
- •6) Node positive disease (positive sentinel node or positive axillary clearance) (N+)
- •or node negative disease (N-) with the following criteria : SBR II / III and pT>20mm
- •7) Patient presenting one of the following criteria :
- •o for N+ patients: triple negative tumor [HER2 negative and ER negative and PR negative] or [HER2 negative and PR negative status],
- •o for N- patients: triple negative tumor only [HER2 negative and ER negative and PR negative]
- •HER 2 negativity is defined as IHC 0, or IHC 1+, or [IHC 2+ and FISH or CISH negative].
- •Hormonal receptor (progesterone and estrogen receptors) negativity is defined as a rate <10% in immunohistochemistry.
- •All tumors will be centrally analysed before randomization by a regional web
- •of reference pathologists to assess final diagnosis of HER2 expression and hormonal receptor status.
- •8) No clinically or radiologically detectable metastases (M0)
- •9) No peripheral neuropathy > 1
- •10) WHO Performance status (ECOG) of 0 or 1
- •11) Adequate recovery from recent surgery (at least one week must have elapsed from the time of a minor surgery (excluding breast biopsy); at least three weeks for major surgery)
- •12) Adequate hematological function (neutrophil count = 2x109/l
- •platelet count =100x 109/l, Hemoglobin > 9g/dl)
- •13) Adequate hepatic function: ASAT and ALAT = 1.5 ULN, alkaline phosphatase = 2.5 ULN, total bilirubin = 1.0 ULN
- •14) Adequate renal function: serum creatinine = 1.5 ULN
- •15) Patients accepting contraception intake during the overall length of treatment
- •if of childbearing potential
- •16) Adequate cardiac function, LEVF value = 50% by Muga scan or echocardiography,
- •17) Signed written informed consent.
- •Women of childbearing potential (WOCBP) must be using an adequate method
- •of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of chemotherapy in such a manner that the risk of pregnancy is minimized. WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophrectomy) or is not postmenopausal [defined as amenorrhea = 12 consecutive months; or women on hormone replacement therapy (HRT)
- •with documented serum follicle stimulating hormone (FSH) level > 30 IU/l]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
- •25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Bilateral breast cancer or patient with controlateral DCIS
- •2) Any metastatic impairment, including homolateral sub-clavicular node involvement
- •regardless of its type
- •3) Any tumor ? T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer)
- •4) HER2 overexpression defined as [IHC 3+] or [IHC 2+ and FISH or CISH positive]
- •5) Any clinically or radiologically suspect and non-explored damage to the controlateral breast
- •6) Any chemotherapy, hormonal therapy or radiotherapy before surgery
- •7) Concomittant treatment with the following strong inhibitors of CYP3A4 from 72 hours prior to the initiation of study therapy until end of treatment with ixabepilone or docetaxel: amiodarone, clarithromycin, amprenavir, delavirdine, voriconazole erythromycin, fluconazole, itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, and saquinavir
- •8) Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin peripheral ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer
- •9) Patients already included in another therapeutic trial involving an experimental drug
- •10) Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study
- •11) LEVF < 50% (MUGA scan or echocardiography)
- •12) Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (>150/90), myocardial infarction or cerebral vascular accidents) within 6 months prior to randomization
- •13) Known prior severe hypersensitivity reactions to agents containing Cremophor EL
- •14) Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up
- •to 8 weeks after treatment completion
- •15) Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase
- •16) Women with a positive pregnancy test en enrollment or prior to study drug administration,
- •17) Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •18) Individual deprived of liberty or placed under the authority of a tutor.
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