EUCTR2006-006010-15-IT进行中（未招募）不适用
PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CISPLATINUMAND FLUOROURACIL AS CONTINUOUS INFUSION (CCF) PLUSTRASTUZUMAB (HERCEPTIN) IN THE PREOPERATIVE TREATMENT OFLOCALLY ADVANCED BREAST CANCER - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- All
入选标准
- •? Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 ad,
- •N0-3c, M0) or
- •Patients with histologically proven local recurrence after breast conserving surgery (rT1-
- •T4, N0-3c, M0) or
- •Patients with histologically proven local recurrence after mastectomy (M1 on the chest
- •Patients with histological proven regional recurrence (axillary, suvraclavicular and internal
- •mammary chain lymph nodes)
- •? Patients with HER2 overexpression (+++)or with Her2/neu gene amplification
- •? Patients must be suitable for local treatment (radiotherapy and/or surgery) in a
- •multidisciplinary program
- •? Bilateral breast cancers are eligible
- •? Women aged 18?75 years
- •? ER PgR and c-erbB-2 expression defined according to EIO guidelines
- •? Performance status 0-2 (ECOG scale)
- •? Measurable and/or evaluable lesions
- •? No evidence of distant metastatic disease
- •? No clinically significant concomitant illness such as diabetes, cardiovascular, renal, or
- •neurological impairments
- •? LVEF >= 55% at basal echocardiography
- •? Absence of psychiatric illness undermining a correct understanding of the treatment
- •? WBC > 3,000/mm3; PLTS > 100,000/mm3
- •? AST, ALT, gamma-GT < 2.5 x upper normal limit and bilirubin < 1.5 mg/dl
- •? Serum creatinine in the normal range
- •? Institutional Signed Written Informed Consent obtained
- •? Pregnancy test (in fertile women). An effective contraceptive method must be prescribed
- •and its use verified for all women at potential risk of pregnancy
- •? Patients could have received prior anthracycline-including chemotherapy regimen for
- •breast cancer with a cumulative dose of doxorubicin<= 350 mg/m2 or epirubicin <= 720
- •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
- •Absence of HER2/neu overexpression or amplification with FISH-test
- •? Patients with other non-malignant uncontrolled systemic diseases that would
- •preclude trial entry in the opinion of the investigator. Specifically not eligible are
- •patients with uncontrolled active infection, chronic infection such as active HBV or
- •? Patients with distant metastatic disease
- •? Clinical grade greater than or equal to 2 peripheral neuropathy.
- •? Previous adjuvant and/or neoadjuvant treatment with anthracyclines, cisplatin and/or
- •5-FU ended less than 12 months before study entry
- •? Previous adjuvant and/or neoadjuvant treatment with trastuzumab ended less than 6
- •months before study entry
研究者
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