EUCTR2004-000618-38-GB进行中（未招募）1 期
A randomized, open-label, phase III study of RPR109881 IV every 3 weeks versus capecitabine (Xeloda®) tablets twice daily for 2 weeks in 3-week cycles in patients with metastatic breast cancer progressing after taxanes and anthracycline 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
- 800
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
入选标准
- •- Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now metastatic (TXNXM1) or locally recurrent and inoperable with curative intent.
- •- All patients must have received an anthracycline and a taxane prior to entry in the protocol. These drugs may have been given in the adjuvant or in the metastatic setting, may have been given concurrently or sequentially, and may have been given in combination with other drugs. Patients must have received a standard dose of anthracycline and of taxane expected to have potentially resulted in a response.
- •For taxanes:
- •a) Patients must have progressed while receiving paclitaxel or docetaxel therapy or at any time after having received paclitaxel or docetaxel therapy.
- •b) The taxane-based treatment must have been the last chemotherapy the patient received.
- •For anthracyclines:
- •Patients must have either:
- •a) Progressed while on anthracycline treatment, with or without an initial response,
- •b) Patients must have received an adequate course of anthracyclines defined as follows:
- •i. In the adjuvant setting, patients must have received a regimen considered standard for adjuvant therapy, which would usually result in a cumulative dose of doxorubicin of 240-300 mg/m2 or doxorubicin equivalent.
- •ii. In the metastatic setting patients must have received a regimen considered standard for therapy for metastatic disease, which would usually result in a cumulative dose of doxorubicin of at least 300 mg/m2 or doxorubicin equivalent.
- •- Evidence of measurable disease as defined by RECIST.
- •- Completion of all prior chemotherapy, immunotherapy (including trastuzumab [Herceptin]), targeted non-cytotoxic therapy, and radiotherapy 3 weeks or more than 3 weeks prior to study entry.
- •- ECOG (Eastern Cooperative Oncology Group) performance status of 0,1, or 2.
- •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
- •- 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 any other in situ cancer must be discussed with the sponsor. Patients with a history of contralateral breast cancer who have been disease-free for more than 5 years prior to randomization are permitted.
- •- Prior treatment with capecitabine or any taxanes analogs except for paclitaxel or docetaxel (eg, epothilones are not permitted, novel preparations of paclitaxel are not permitted, generic paclitaxel is permitted).
- •- Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement).
- •- Concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy (including trastuzumab [Herceptin]), hormonal therapy, radiotherapy, chemoembolization therapy, cryotherapy, targeted non-cytotoxic therapies or patients planning to receive these treatments during the study.
- •- Known human immunodeficiency virus (HIV) infection requiring treatment or acquired immunodeficiency-syndrome (AIDS)-related illness.
- •- HER-2 positive patients may participate in this trial. Concurrent treatment with trastuzumab [Herceptin] is not permitted.
- •- Concurrent treatment with potent inhibitors of cytochrome P450 3A4, such as ketoconazole, itraconazole, erythromycin, clarythromycin or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization.
- •- Patients who are pregnant or breastfeeding.
研究者
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Randomized, open-label, phase III study of RPR109881 IV every 3 weeks versus capecitabine (Xeloda®) tablets administered twice daily for 2 weeks in 3-week cycles in patients with progressive metastatic breast cancer after therapy with taxanes and anthracyclines-C509 Breast, unspecifiedBreast, unspecifiedC509PER-011-05AVENTIS PHARMA S.A.,
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