NCT01910844终止2 期
Phase II Pilot Study Assessing Efficacy of a Cisplatin - Métronomic Cyclophosphamide Treatment in Patients With Stade IV Triple Negative Breast Cancer Secondary Resistant to Anthracyclines and Taxanes
Centre Jean Perrin1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Response rate of cisplatine - metronomic cyclophosphamide treatment
研究概览
简要总结
Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Performance status < 2,
- •Patient with metastatic breast cancer stade IV triple negative histologically confirmed
- •Measurable 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, Alkaline 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 ≥ 60 mL/min) or Clearance ≥ 40 mL/min in case of RMI,
- •Patient signed the consent study form,
- •Patient affiliated to a social security regimen (law of 9 August 2004).
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 insufficiency, clinically significant cardiovascular disease (including myocardiac infarct, 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-convulsive).
- •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 study.
研究组 & 干预措施
Cisplatin - Metronomic Cyclophosphamide
Experimental
Cisplatin 25 mg/m² from day 1 to day 3 every 3 weeks Metronomic Cyclophosphamide 150 mg from day 1 to day 14 every 3 weeks
干预措施: Cisplatin (Drug)
Cisplatin - Metronomic Cyclophosphamide
Experimental
Cisplatin 25 mg/m² from day 1 to day 3 every 3 weeks Metronomic Cyclophosphamide 150 mg from day 1 to day 14 every 3 weeks
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Response rate of cisplatine - metronomic cyclophosphamide treatment
时间窗: 12 months and 6 weeks
次要结局
- Predictive factors to response and/or resistance treatment(12 months and 6 weeks)
- Disease free progression(3 years)
- Safety profile of cisplatin - metronomic cyclophosphamide association(12 months and 6 weeks)
- Overall survival(5 years)
研究者
研究点 (1)
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