EUCTR2011-003832-30-NL进行中（未招募）1 期
The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician?s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine - BEACO
ektar Therapeutics0 个研究点目标入组 840 人开始时间: 2012年5月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 840
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
- •Patient is an adult female with histologically or cytologically confirmed
- •carcinoma of the breast for whom single-agent cytotoxic chemotherapy
- •is indicated. Patients may have either measurable disease by RECIST
- •version 1.1 or non-measurable disease.
- •Locally recurrent or metastatic disease that is not resectable or
- •amenable to curative treatment.
- •Patient has received prior therapy (administered in the neoadjuvant,
- •adjuvant and/or metastatic setting) with an anthracycline, a taxane and
- •capecitabine
- •Patient has minimum of 2 and a maximum of 5 prior cytotoxic
- •chemotherapy regimens with the last dose administered within 6
- •months. A minimum of two chemotherapy regimens had to be for locally
- •recurrent and/or metastatic disease. All therapy received prior to a
- •diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated
- •adjuvant therapy following a second resection) is counted as one
- •regimen. Treatment regimens for ipsilateral and/or contralateral
- •recurrent disease (ie, multiple adjuvant therapies) are permitted and all
- •counted as one regimen.
- •Patient has Eastern Cooperative Oncology Group (ECOG) performance
- •status of 0 or 1.
- •Adequate hematopoietic, liver and kidney functions.
- •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 672
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •Patient who have had a last dose of IV chemotherapy within 21 days,
- •last dose of oral chemotherapy, radiotherapy, biological therapy, or
- •investigational therapy within 14 days or hormonal therapy within 7
- •days prior to randomization. Patients who have undergone high-dose
- •chemotherapy followed by stem cell transplantation (autologous or
- •allogeneic). Refer to the Study Reference Manual for categories of
- •anticancer therapies.
- •Patient with any major surgery within 28 days prior to randomization.
- •Patient with concurrent use of biologic agents for the treatment of
- •cancer including antibodies or any investigational agent(s).
- •Patient with prior treatment for cancer with a camptothecin derivative.
- •Patient with chronic or acute GI disorders resulting in diarrhea of any
- •severity grade; patients who are using chronic anti-diarrheal supportive
- •care to control diarrhea in the 28 days prior to randomization.
- •Patient received pharmacotherapy for hepatitis B or C, tuberculosis or
- •Patient with known cirrhosis diagnosed with Child-PUGH Class A or
- •higher liver disease.
- •Patient with prior malignancy (other than breast cancer) except for
- •non-melanoma skin cancer and carcinoma in situ (of the cervix or
- •bladder), unless diagnosed and definitively treated more than 5 years
- •prior to randomization.
- •Patient requiring daily use of oxygen supplementation in the 28 days
- •prior to randomization.
- •Patients with significant cardiovascular impairment.
研究者
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