EUCTR2006-006474-21-FR进行中（未招募）1 期
A dose-escalating, multicenter, single arm, open-label study of XRP9881 in combination with capecitabine (Xeloda®), in metastatic breast cancer patients with disease progressing after anthracycline and taxane therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •1. Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic or locally recurrent and inoperable with curative intent. Patients with previously treated histo/cytologically confirmed disease who develop clinical or radiological evidence of metastatic disease do not require separate confirmation of the metastatic disease.
- •2. Patients must have received an anthracycline and a taxane prior to entry in the protocol. These drugs may have been given in the neoadjuvant/adjuvant or in the metastatic setting, may have been given concurrently or sequentially, and may have been given in combination with other drugs. Patients should have received a standard dose of anthracycline and of taxane expected to have potentially resulted in a response. For Part I only, patients who have received at least a prior regimen with either an anthracycline or a taxane are eligible
- •3. Female patients at least 18 years old.
- •4. Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). For the part I component, patients with non-measurable disease are accepted
- •5. Completion of all prior chemotherapy, biological therapy, targeted non-cytotoxic therapy, and radiotherapy = 3 weeks prior to registration. For part 2 only, Prior treatment with radiotherapy, chemoembolization therapy, or cryotherapy is allowed if these therapies are not directed to the areas of measurable disease being used for the purposes of this protocol.
- •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
- •1. History of any second malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. Inclusion of patients with any other in situ cancer or a history of an invasive cancer with complete remission for 5 or more years must be discussed with the sponsor and the principal investigator. Patients with a history of contralateral breast cancer who have been disease-free for more than 5 years prior to registration are permitted.
- •2. The following breast cancer treatments for part II only:
- •a. Patients receiving more than one adjuvant regimen. However, patients who have received neoadjuvant therapy immediately followed by surgery and immediately followed by adjuvant therapy without intervening progression are considered to have received one adjuvant regimen and are allowed in the trial.
- •b. Patients receiving more than one chemotherapy regimen for metastatic or locally recurrent and inoperable breast cancer. A chemotherapy regimen is defined as a single or a combination of chemotherapy agents given until documented disease progression or relapse. For example, patients who received sequential doxorubicin and docetaxel in the metastatic setting without intervening progression are allowed in the trial as this is considered one CT regimen.
- •3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
- •4. Prior treatment with capecitabine, XRP9881 or any investigational chemotherapy. Docetaxel, Paclitaxel (and generic) and Abraxane® (nanoparticle albumin-bound paclitaxel ) are permitted.
- •5. History of hypersensitivity grade = 3 to taxanes, Polysorbate-80, or to compounds with similar chemical structures. Patients with known intolerance to fluoropyrimidines or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •6. Peripheral neuropathy grade = 2.
- •7. Any of the following within the 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4).
研究者
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