EUCTR2010-020835-38-IT进行中（未招募）不适用
A phase II study of cisplatin plus cyclophospamide for patients with previously treated, advanced, triple receptor negative breast cancer”
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
- Female
入选标准
- •Histologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent. • Documentation of Estrogen and Progestin Receptor (ER and PgR) negative status (immunohistochemistry 0%) and HER2/neu receptor negative status (i.e., FISH negative or immunohistochemistry 0 or +1). • Prior treatment with an anthracycline and/or a taxanes in the neoadjuvant, adjuvant or metastatic disease setting. • Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not considered target lesions unless increase in size has been observed following completion of radiation therapy. • Female, 18 years of age or older. • ECOG performance status 0, 1 or 2. • Resolution of all acute toxic effects of prior therapy or surgical procedures to grade = 1 (except alopecia). • The definitions of minimum adequacy for organ function required prior to study entry
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Major surgery, radiation therapy, or systemic therapy within 3 weeks of study enrollment except palliative radiotherapy to non-target metastatic lesions. • Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomenigeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic. • Diagnosis of any second malignancy within the last 3 years, except for contralateral breast cancer also with triple negative receptor status, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervic. • Any of the following within the 2 months prior to starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure, cerebrovascular accident including transient attack, or pulmonary embolus not correlated to the breast cancer. • Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2 or atrial fibrillation of any grade. • Current treatment with therapeutic doses of coumarin or oral anti-vitamin K agents such as warfarin and phenprocoumon derivates. Low molecular weight heparin is allowed at any dose level. • Known human immunodeficiency virus infection. • Female who is pregnant or nursing; female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the trial and for 3 months after the last dose of study treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization. Female patients must be surgically sterile or be in postmenopausal, or must agree to use effective contraception during the period of therapy and for 3 months after the last dose of study treatment. • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which in the judgment of the investigator, would make the patient inappropriate for entry into this study. • Acute kidney injury or failure within 3 months prior to starting study treatment. • Current treatment with drug-related nephrotoxic effects. • Ongoing condition described as 'urethral' (or 'dysuria/frequency') syndrome.
研究者
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