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2007年3月26日

概览

暂无简介。

注册库

who.int

开始日期

2007年3月26日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

发起方

Fédérationa Nationale des Centres de Lutte Contre le Cancer

•\- 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]

•\- 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,