EUCTR2012-005213-39-FR进行中（未招募）不适用
Phase II pilot study assessing efficacy of a Cisplatine – MétronomicCyclophosphamide treatment in Patients with Stade IV Triple Negativebreast Cancer Secondary Resistant to Anthracyclines and Taxanes - META2
CENTRE JEAN PERRI0 个研究点开始时间: 2013年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Age > 18 ans,
- •Performance status < 2,
- •Patient with metastatic breast cancer stade IV triple negative
- •histologically confirmed
- •Mesurable or not disease but radiologically evaluable (RECIST 1.1),
- •Negative Hormonal Receptors (Estrogens and/or Progesterone),
- •HER-2 negative (Score 0 or 1 by Immunochemistry (IHC), negative FISH if score IHC 2),
- •Patient exposed to anthracyclines and/or taxanes in neo-adjuvant or adjuvant setting,
- •Patient with a progression and for whom anthracyclines and/or
- •taxanes treatment cannot be delivered and according to a resistance defined as :
- •- In the last 12 months after the last dose of taxanes or anthracyclines in adjuvant or neoadjuvant setting or,
- •- During or after a first metastatic chemtotherapy line and where taxanes and anthracyclines cannot be delivered according to :
- •- either a secondary resistance after an initial response to chemotherapy but a relapse observed either during the treatment or in the 4 months after the end of chemotherapy.
- •- either a sensitivity to treatment defined by a relapse after more than 4 months after the first chemotherapy metastatic line,
- •- either intolerance to anthracyclines (doxorubicin 240-400 mg/m² ou equivalent to doxorubicin (epirubicin) 300-550mg/m²)
- •Patient non previously treated by platinum salts,
- •Hematological Functions: Neutrophiles = 1,5.109/L, Platelets =
- •100.109/L, Leucocytes > 3 000/mm3, Hb > 9g/dL,
- •Hepatic Functions : total Bilirubin = 1,5 time upper normal value (UNV), ASAT = 2 ,5 time UNV, ALAT = 2,5 time UNV, Alcaline Phosphatase = 2,5 time UNV (< 5 time UNV if case of hepatic metastasis),
- •Renal Functions: Serum Creatinine = 1,5 time UNV (and if value > 1,5 time UNV, so Clearance = 50 mL/min) or Clearance = 40 mL/min in case of RMI,
- •Patient signed the consent study form,
- •Patient affilated to a social security regimen (law of 9 August 2004).
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Male Patients,
- •Unknown hormonal Receptors
- •Positive HER-2 (Score 3 in IHC or positive FISH)
- •Pregnant or breastfeeding patient, or in age of pregnancy or predicting to be pregnant in the 6 months after the end of treatment,
- •Patient not using contraceptive treatment during the treatment or after the 6 months after the end of treatment,
- •Patient is a ward,
- •Patient suffering from a non compatible disease with the enrollment in the study,
- •Cardiac, renal, medullar, respiratory or hepatic insuffisancy,
- •clinically significant cardiovascular disease (including myocardic
- •infarctus, unstable angina, symptomatic congestive heart failure,
- •uncontrolled cardiac arrhythmia) < 1 year before the study enrollment or randomisation,
- •Patient with pulmonary lymphangitis or symptomatic pleural effusion (grade=2), meningeal known carcinoma or symptoms of cerebromeningeal invasion, brain metastases unless treatment and stability for at least 4 weeks (no steroids or anti-convulsives).
- •Uncontrolled diabetes,
- •Psychiatric or neurological significant abnormality,
- •Peripheric Neuropathy > grade 2,
- •Antecedent of hypersensibility to one of study treatment or one of used excipients,
- •Urinary tract infection or acute hemorrhagic cystitis in progress
- •Concomitant treatment with a medicine containing phenytoin or
- •medication received in the context of a trial, or participation in another therapeutic clinical trial within <30 days prior treatment with chemotherapy.
- •Geographically unstable patient in the next 6 months or remaining
- •distance to the treatment center making it difficult to follow in the study,
- •Known history of abuse of narcotic or other drug or alcohol
- •History of surgery within 28 days before the start of treatment,
- •Patient unwilling or unable to comply with the requirements of the
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