EUCTR2006-006494-24-FR进行中（未招募）1 期
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
Fédérationa 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3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
入选标准
- •- Women aged from 18 to 70 years,
- •- Histologically proven invasive unilateral breast cancer (regardless of the type),
- •- Initial clinical condition compatible with complete initial resection,
- •- No residual macro or microscopic tumor after surgical excision,
- •- Beginning of chemotherapeutic treatment no later than day 42 after the initial surgery,
- •- 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,
- •- Patient presenting one of the following criteria :
- •- for N+ patients: triple negative tumor [HER2 negative and ER negative and PR negative] or [HER2 negative and PR negative status],
- •- 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.
- •- No clinically or radiologically detectable metastases (M0),
- •- No peripheral neuropathy > 1,
- •- WHO Performance status (ECOG) of 0 or 1,
- •- 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),
- •- Adequate hematological function (neutrophil count = 2x109/l,
- •platelet count = 100x 109/l, Hemoglobin > 9g/dl),
- •- Adequate hepatic function: ASAT and ALAT = 1.5 ULN, alkaline phosphatase = 2.5 ULN, total bilirubin = 1.5 ULN,
- •- Adequate renal function: serum creatinine = 1.5 ULN,
- •- Patients accepting contraception intake during the overall length of treatment if of childbearing potential,
- •- Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography,
- •- Signed written informed consent.
- •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
- •- Bilateral breast cancer or patient with controlateral DCIS,
- •- Any metastatic impairment, including homolateral sub-clavicular node involvement, regardless of its type,
- •- Any tumor = T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
- •- HER2 overexpression defined as [IHC 3+] or [IHC 2+ and FISH or CISH positive],
- •- Any clinically or radiologically suspect and non-explored damage to the controlateral breast,
- •- Any chemotherapy, hormonal therapy or radiotherapy before surgery,
- •- 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.
- •- Previous cancer (excepted cutaneous baso-cellular epithelioma or uterin pheripheral ephitelioma) in the preceding 5 years, including invasive controlateral breast cancer,
- •- Patients already included in another therapeutic trial involving an experimental drug,
- •- Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study,
- •- LEVF < 50% (MUGA scan or echocardiography),
- •- Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension (>150/90), myocardial infaction or cerebral vascular accidents) within 6 months prior to randomization,
- •- Known prior severe hypersensitivity reactions to agents containing Cremophor EL,
- •- 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,
- •- Women who are pregnant or breastfeeding. Adequate birth control measures should be taken during study treatment phase,
- •- Women with a positive pregnancy test en enrollment or prior to study drug administration,
- •- 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,
- •- Individual deprived of liberty or placed under the authority of a tutor.
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